Development of a core outcome set and outcome definitions for studies on uterus-sparing treatments of adenomyosis (COSAR): an international multistakeholder-modified Delphi consensus study.

STUDY QUESTION: What outcomes should be reported in all studies investigating uterus-sparing interventions for treating uterine adenomyosis? SUMMARY ANSWER: We identified 24 specific and 26 generic core outcomes in nine domains. WHAT IS KNOWN ALREADY: Research reporting adenomyosis treatment is not patient-centred and shows wide variation in outcome selection, definition, reporting and measurement of quality. STUDY DESIGN, SIZE, DURATION: An international consensus development process was performed between March and December 2021. Participants in round one were 150 healthcare professionals, 17 researchers and 334 individuals or partners with lived experience of adenomyosis from 48 high-, middle- and low-income countries. There were 291 participants in the second round. PARTICIPANTS/MATERIALS, SETTING, METHODS: Stakeholders included active researchers in the field, healthcare professionals involved in diagnosis and treatment, and people and their partners with lived experience of adenomyosis. The core component of the process was a 2-step modified Delphi electronic survey. The Steering Committee analysed the results and created the final core outcome set (COS) in a semi-structured meeting. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 241 outcomes was identified and distilled into a 'long list' of 71 potential outcomes. The final COS comprises 24 specific and 26 generic core outcomes across nine domains, including pain, uterine bleeding, reproductive outcomes, haematology, urinary system, life impact, delivery of care, adverse events and reporting items, all with definitions provided by the Steering Committee. Nineteen of these outcomes will apply only to certain study types. Although not included in the COS, the Steering Committee recommended that three health economic outcomes should be recorded. LIMITATIONS, REASONS FOR CAUTION: Patients from continents other than Europe were under-represented in this survey. A lack of translation of the survey might have limited the active participation of people in non-English speaking countries. Only 58% of participants returned to round two, but analysis did not indicate attrition bias. There is a significant lack of scientific evidence regarding which symptoms are caused by adenomyosis and when they are related to other co-existent disorders such as endometriosis. As future research provides more clarity, the appropriate review and revision of the COS will be necessary. WIDER IMPLICATIONS OF THE FINDINGS: Implementing this COS in future studies on the treatment of adenomyosis will improve the quality of reporting and aid evidence synthesis. STUDY FUNDING/COMPETING INTEREST(S): No specific funding was received for this work. T.T. received a grant (grant number 2020083) from the South Eastern Norwegian Health Authority during the course of this work. T.T. receives personal fees from General Electrics and Medtronic for lectures on ultrasound. E.R.L. is the chairman of the Norwegian Endometriosis Association. M.G.M. is a consultant for Abbvie Inc and Myovant, receives research funding from AbbVie and is Chair of the Women's Health Research Collaborative. S.-W.G. is a board member of the Asian Society of Endometriosis and Adenomyosis, on the scientific advisory board of the endometriosis foundation of America, previous congress chair for the World Endometriosis Society, for none of which he received personal fees. E.S. received outside of this work grants for two multicentre trials on endometriosis from the National Institute for Health Research UK, the Rosetrees Trust, and the Barts and the London Charity, he is a member of the Medicines and Healthcare Products Regulatory Agency (MHRA), Medicines for Women's Health Expert Advisory Group, he is an ambassador for the World Endometriosis Society, and he received personal fees for lectures from Hologic, Olympus, Medtronic, Johnson & Johnson, Intuitive and Karl Storz. M.H. is member of the British Society for Gynaecological Endoscopy subcommittee. No other conflict of interest was declared. TRIAL REGISTRATION NUMBER: N/A.

A comparison of maternal calcium and magnesium levels in pre-eclamptic and normotensive pregnancies: an observational case-control study.

OBJECTIVE: Supplementing pregnant women at high risk of developing pre-eclampsia with calcium may reduce the incidence of the disease. This study examines differences in serum and hair concentrations of calcium and magnesium between women with pre-eclamptic and normotensive pregnancies. DESIGN: Observational case-control study. SETTING: Two teaching hospitals in Cape Town, South Africa. POPULATION: Women with pre-eclamptic (N = 96) or normotensive (N = 96) pregnancies, who delivered a single, live infant. METHODS: Demographic and current pregnancy details were retrieved from clinical notes. Each participant completed a dietary questionnaire. Venous blood samples were taken from each participant to assess serum calcium and magnesium concentrations. Hair samples were obtained from all participants and calcium and magnesium levels were measured by inductively coupled plasma optical emission spectrometry (ICPOES). MAIN OUTCOME MEASURE: Hair and serum calcium and magnesium concentrations were compared between women with pre-eclamptic and normotensive pregnancies. RESULTS: Diet and socio-economic status in the two groups were similar. There was no significant difference in the hair calcium level between women with pre-eclamptic [1241 parts per million (ppm); range, 331-4654 ppm] and normotensive (1146 ppm; range, 480-4136 ppm) pregnancies (P = 0.5). Hair calcium levels in both groups were not affected by HIV infection. CONCLUSION: Woman with pre-eclampsia showed no difference in chronic calcium status relative to normotensive women. This finding does not support the current belief that the mechanism by which calcium supplementation reduces the risk of developing pre-eclampsia is by correcting a nutritional deficiency.

Zoladex (goserelin acetate) and the anemic patient: results of a multicenter fibroid study.

OBJECTIVE: To compare the effects of goserelin acetate treatment with or without iron with iron alone. DESIGN: Multinational, multicenter, prospective, randomized, double-blind study. PATIENTS: Premenopausal women with menorrhagia or metrorrhagia and anemia associated with uterine leiomyomata awaiting hysterectomy. INTERVENTION: Patients were randomized to one of three 12-week treatment groups namely goserelin acetate 3.6 mg once monthly plus placebo iron; 3.6 mg goserelin acetate once monthly plus 600 mg/d iron; or sham injection once monthly plus 600 mg/d iron. MAIN OUTCOME MEASURE: Preoperative hemoglobin concentration; preoperative uterine and fibroid volumes and operative blood loss. RESULTS: Considering the entry and preoperative hemoglobin concentrations, there was a difference in least square means of just over 1 g/dL between the goserelin acetate plus iron and iron only groups and 2.6 g/dL between the goserelin acetate plus iron and goserelin acetate only group. These differences were both statistically significant. Uterine and fibroid volumes were decreased in the goserelin acetate-treated patients by between 37% and 40% and 44% and 47%, respectively, compared with 7% decreases for both in the iron only group. The differences in absolute changes were statistically significant for both the goserelin acetate-treated groups versus the iron-treated group. The least square geometric mean operative blood loss was greatest in the iron only group. CONCLUSION: In the patient with uterine leiomyomata and anemia, goserelin acetate in combination with iron therapy has shown significant advantages over the iron alone in restoring hematologic normality, decreasing uterine and fibroid volumes, and reducing operative blood loss.

Is postpartum contraceptive advice given antenatally of value?

In response to the concept that a good postpartum program should begin prenatally, this study was designed to determine whether the provision of expert contraceptive counseling during the antenatal period would have an impact on contraceptive uptake, patterns of contraceptive usage, and pregnancy rates during the first year after childbirth. Over 500 women attending antenatal clinics in each of three centers (Edinburgh, Scotland; Shanghai, People's Republic of China; Cape Town, South Africa) were randomized to receive expert contraceptive advice (participants, n = 771) or the standard advice routinely given in that setting (controls, n = 866). Follow-up was by postal or interviewer-administered questionnaires at 16 and 52 weeks after childbirth. There were no significant differences in the prevalence of contraceptive use at one year (over 79% in all centers) between participants and controls. In Edinburgh, participants were more likely to undergo sterilization (p < 0.01) than controls, otherwise there were no differences among Edinburgh, Shanghai, or Cape Town in either the methods of contraception chosen or in the methods used over time. Contraceptive counseling delivered antenatally appeared to have no impact on the pregnancy rate during the first year after childbirth. In Shanghai, over 11% of women in both groups underwent termination of pregnancy in the year of follow-up. In conclusion, although women in all centers said they found the opportunity to discuss contraception antenatally was useful, it had very little effect on contraceptive use or on subsequent pregnancy rates.

Gonadotropin and estradiol secretion during the week of placebo therapy in oral contraceptive pill users.

The changes in the hypothalamic-pituitary-ovarian axis during the placebo week in oral contraceptive pill users were assessed. Fifteen women using the combined oral contraceptive pill were studied for eight hours at the start and at the end of the placebo week and gonadotropin secretion and estradiol concentrations were compared with those in control women in the follicular phase of an unmedicated menstrual cycle. Both gonadotropin and estradiol concentrations were suppressed at the start of the placebo week. By day 7 of placebo, gonadotropin concentrations and pulse patterns were indistinguishable from those of the control subjects although estradiol concentrations were still significantly lower.

PIP: The changes in the hypothalamic-pituitary-ovarian axis during the placebo week in oral contraceptive (OC) users were assessed. 15 women who used a combined OC were studied for 8 hours at the start and at the end of the placebo week; gonadotropin secretion and estradiol concentrations were compared with those in control women during the follicular phase of an unmedicated menstrual cycle. Both hormone concentrations were suppressed at the start of the placebo week. By day 7 of placebo, gonadotropin concentrations and pulse patterns were indistinguishable from those of the controls although estradiol concentrations were still significantly lower.

Amenorrhea associated with contraception-an international study on acceptability.

Surveys undertaken in the 1970s and 1980s suggested that amenorrhea was unacceptable to most women, especially in developing countries. More recent research suggests that increasing numbers of women in the developed world prefer to menstruate less often. In a questionnaire survey of 1001 women attending family-planning clinics and 290 contraceptive providers in China, South Africa, Nigeria and Scotland, only among black women in Africa did the majority like having periods. In all other groups, most women disliked periods, which were "inconvenient" and associated with menstrual problems. Given the choice, the majority of Nigerian women would prefer to bleed monthly. Elsewhere, women would opt to bleed only once every 3 months, or not at all. In all except the Chinese centers, the majority of women would be willing to try a contraceptive which induced amenorrhea. Providers tended to overestimate the importance of regular menstruation to their clients. This is an important observation for scientists and funding agencies involved in developing new methods of contraception.

Cyproterone acetate for hirsutism.

BACKGROUND: Hirsutism is a distressing and relatively common endocrine problem in women which may prove difficult to manage. Cyproterone acetate, an anti-androgen, is frequently used to treat hirsutism, usually in combination with ethinyl estradiol. OBJECTIVES: The objective of this review was to investigate the effectiveness of cyproterone acetate alone, or in combination with ethinyl estradiol, in reducing hair growth in women with hirsutism secondary to ovarian hyperandrogenism. SEARCH STRATEGY: The Cochrane Menstrual Disorders and Subfertility Group trials register was searched (last search - 4 June 2002). The Cochrane Menstrual Disorders and Subfertility Group register is based on regular searches of MEDLINE (1966 to 2002), EMBASE (1980 to 2002), CINAHL (1982 to 2002), PsycINFO (1987 to 2002) and CENTRAL (Issue 2, 2002 of the Cochrane Library) the handsearching of several journals and conference proceedings, and searches of several key grey literature sources. All publications of randomised controlled trials of cyproterone acetate with or without estrogen versus placebo or other drug therapies for hirsutism were identified. SELECTION CRITERIA: All randomised controlled studies comparing:- cyproterone acetate to placebo- cyproterone acetate with ethinyl estradiol to placebo- cyproterone acetate with ethinyl estradiol to cyproterone acetate alone- cyproterone acetate (with or without estradiol) to other medical therapies for treatment of hirsutism. DATA COLLECTION AND ANALYSIS: Eleven studies were identified which fulfilled the inclusion criteria. Nine randomised studies were included in the review, and two were excluded because of insufficient information. Only one study had more than 100 women included in the analysis. The major outcomes included: subjective improvement in hirsutism, changes in Ferriman Gallwey scores, changes in linear hair growth and hair shaft diameter, alterations in endocrine parameters, side effects to treatment, withdrawals during therapy MAIN RESULTS: There were no clinical trials comparing cyproterone acetate alone with placebo. There was one small study comparing cyproterone acetate in combination with ethinyl estradiol to placebo. In this study there was a significant subjective reduction in hair growth with cyproterone acetate therapy, although the confidence limits were large. There were no studies comparing cyproterone acetate alone with cyproterone acetate in combination with ethinyl estradiol to treat hirsutism. In studies where cyproterone acetate was compared to other drug modalities (ketoconazole, spironolactone, flutamide, finasteride, GnRH analogues) no difference in clinical outcome was noted. There were, however, endocrinological differences in androgen and estrogen levels between different drug therapies. There were insufficient data to assess differences in side effects between women treated with cyproterone acetate and other medical therapy. REVIEWER'S CONCLUSIONS: Cyproterone acetate combined with estradiol results in a subjective improvement in hirsutism compared to placebo. Clinical differences in outcome between cyproterone acetate and other medical therapies were not demonstrated in the studies included in this review. This may be because of the small size of the studies, lack of standardized assessment and lack of objective determinants of improvement in hirsutism. The endocrinological effects of the different drug therapies reflect the mode of action. Larger carefully designed studies are needed to compare efficacy and safety profiles between drug therapies for hirsutism.

The effect of emotional support on maternal oxytocin levels in labouring women.

OBJECTIVE: The presence of a supportive companion to women in labour has been found to reduce the duration of labour and the incidence of oxytocin augmentation. The mechanism which produces this improvement is unknown but work in animals suggests that environmental disturbance produces changes in endogenous oxytocin secretion. This study was carried out to assess maternal oxytocin secretion in relation to the presence of a supportive companion in labour. STUDY DESIGN: A randomised controlled trial involving allocation of unsupported women in the first stage of labour to a period of 1 h with a supportive companion or 1 h without. Sixteen women with uncomplicated singleton pregnancies who were in the active phase of the first stage of labour were studied. Maternal oxytocin levels were assayed by radioimmunoassay for 16 min (eight specimens) before and after the support or control period. RESULTS: There are no differences between maternal oxytocin levels in the two groups of patients. There was no difference in either of the two groups between the oxytocin levels pre and post the support/control period. CONCLUSIONS: One hour of birth support in the first stage of labour did not improve maternal oxytocin levels when compared to a control group.

A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel).

BACKGROUND: The acceptability and continuation rate of oral contraceptive steroids are limited by unpredictable bleeding and the fear of long-term risks such as breast cancer. By inhibiting ovulation and by altering the receptivity of the endometrium, antagonists of progesterone, such as mifepristone, could be developed as estrogen-free novel contraceptives. METHODS: Multicentre, double-blind, randomized controlled trial comparing frequency of amenorrhoea (primary outcome), bleeding patterns, side effects and efficacy in women taking daily 5 mg mifepristone (n = 73) or 0.03 mg levonorgestrel (progestogen-only pill; POP, n = 23) for 24 weeks. RESULTS: More women were amenorrhoeic while taking mifepristone than POP (49 versus 0% P < 0.001), and fewer women bled or spotted for >5 days per month (4 versus 39% P < 0.001). Forty-eight percent of women who took mifepristone for 6 months had cystic glandular dilatation of the endometrium but none showed hyperplasia or atypia. There were no pregnancies in 356 months of exposure in women who used only mifepristone for contraception. Two pregnancies occurred in women taking mifepristone who were also using condoms for dual protection. CONCLUSIONS: Daily mifepristone (5 mg) is an effective oral contraceptive pill which has a better pattern of menstrual bleeding than an existing POP (levonorgestrel).

Psychological distress among women suffering from couple infertility in South Africa: a quantitative assessment.

BACKGROUND: Infertility in Africa is commonly associated with negative psycho-social consequences. To date, most studies from African countries addressing these consequences have been qualitative in nature. The aim of this study was to assess psychological distress quantitatively among women suffering from couple infertility in an urban community in South Africa. METHODS: The Symptom Checklist-90-R (SCL-90-R), a standardized instrument for the measurement of current psychological symptom status, was administered to 120 women at the time of their first presentation to an infertility clinic in a tertiary referral centre. The control group comprised 120 women presenting to local family planning clinics. In addition, socio-demographic information and data pertaining to the prevalence of abuse was captured through a structured questionnaire designed for the purpose of this study. RESULTS: Women suffering from involuntary childlessness scored significantly higher on all sub-scales and the global indices of distress of the SCL-90-R when compared to controls. In addition, women who reported abuse from their male partners had significantly higher scores on six of the 12 test scales when compared to infertile women in non-abusive relationships. CONCLUSIONS: Involuntary childlessness is associated with high levels of psychological distress. Women in abusive relationships are particularly at risk. This result is in keeping with several qualitative studies from African countries which describe infertility as an overwhelmingly negative and distressing experience. Cognizance needs to be taken of these experiences and effective interventions require medical, psychological and socio-cultural strategies.

Nutrition and reproduction.

Adequate nutrition is essential for normal reproductive function in man. Menarche occurs at a critical level of 'fatness' and it appears that the hypothalamic events leading to pubertal development and the achievement of reproductive competence may be triggered by metabolic/endocrinological changes due to an increase in fat. The attainment and maintenance of ovulatory cycles demands a minimum degree of body fat (about 22%). Undernutrition results in weight loss and a reduction in fat tissue. This alteration in body composition in turn precipitates the hypothalamic changes that cause impaired gonadotrophin secretion, inappropriate ovarian stimulation and menstrual abnormalities--usually primary or secondary amenorrhoea. Refeeding with restoration of fat tissue will usually result in recovery of reproductive function. There are many causes of undernutrition and the main ones have been discussed. In developed countries the dietary restriction is usually self-imposed--either by rigid control of intake or by the high energy demands of intensive exercise. In contrast to this 'starvation amidst affluence', in developing countries malnutrition is usually the result of inadequate food supplies and poverty. While infertility is often the consequence of undernutrition, many women with suboptimal nutritional states do succeed in becoming pregnant. Malnutrition prejudices pregnancy outcome and results in increased maternal and fetal morbidity and mortality as well as long-term developmental sequelae in the infant. Dietary supplementation is helpful but cannot always overcome the insult caused by the periconceptional undernutrition. The cessation of reproductive function in the undernourished woman represents an adaptive phenomenon, since pregnancy would be prejudicial both to her and the fetus. In view of this, treatment should always aim at refeeding and not at induction of ovulation. Malnourished communities require dietary support and they present the problem of provision of adequate resources. So-called ethnic and culture differences in pubertal development and reproductive performances are in fact often the result of discrepancies in resources and nutrition. Given equal nutritional opportunities these variations may well disappear within a few decades.

Ovarian morphology as a predictor of hormonal values in polycystic ovary syndrome.

The objective of this investigation was to correlate the severity of ultrasound abnormality in the ovaries of women suspected of having the polycystic ovary syndrome (PCOS) with their endocrinopathy in an attempt to establish which anatomical abnormalities best predict endocrine dysfunction. There were 90 patients in the study group--all suspected clinically of having PCOS--and 12 control subjects. Of the study patients, 74 were classified ultrasonically as having polycystic ovaries, whereas 16 demonstrated no ovarian abnormality. On ultrasound examination of the ovaries, the follicular size, the number and type of distribution of follicles, ovarian volume and echogenicity of the stroma were assessed. Levels of the following serum hormones were measured: luteinizing hormone (LH), follicle stimulating hormone (FSH), estrone, estradiol, 17 alpha-OH-progesterone, androstenedione, dehydroepiandrosterone sulfate (DHEAS), sex hormone binding globulin and testosterone. Calculations were made using these results to obtain the LH:FSH ratio and the free androgen index. Endocrine assessment of these 90 patients demonstrated significantly lower LH levels, lower LH:FSH ratio and lower testosterone levels in the women without ovarian abnormality, compared to those with polycystic ovaries. The women with ultrasound evidence of polycystic ovaries had high. LH levels, a raised LH:FSH ratio and higher testosterone, DHEAS and androstenedione levels than the control subjects. Although a number of multivariate regressions of biochemistry on ovarian morphology were statistically significant, ovarian morphology predicted only a small proportion of the variability in the hormone levels. Multivariate regression models predicting androstenedione and the LH:FSH ratio had the best overall fit with ovarian volume and a rosary follicular pattern as factors, but even for these variables the adjusted R2 value was very low (0.23 for androstenedione and 0.20 for the LH:FSH ratio). It is therefore concluded that, although ovarian morphology may accurately diagnose polycystic ovaries, it does not predict the severity or presence of endocrine dysfunction. Management and prognosis must be determined on an individual basis against the background of a combination of the clinical, biochemical and ultrasound findings.

Endocrine function in HIV-infected women.

Infection with the human immunodeficiency virus (HIV) results in a chronic systemic illness with multi-organ involvement, severe immunosuppression and profound cachexia. It has had a major impact on women's health. Endocrine abnormalities may contribute to the clinical presentation and therefore appropriate treatment would theoretically improve the patient's condition. This pilot study was undertaken to assess the endocrine status in a group of HIV seropositive women with the view to developing recommendations for future investigations. Thirteen women were recruited from a clinic for HIV-infected patients. All women had a comprehensive general and gynecological examination. Basal endocrine status was assessed and combined pituitary testing with gonadotropin-releasing hormone, thyrotropin-releasing hormone, growth hormone-releasing hormone and corticotropin-releasing hormone was performed. None of the participating women presented with gynecological complaints or had symptoms suggestive of an endocrinopathy. On questioning, seven women complained of menstrual abnormalities. Three had a body mass index of less than 20 kg/m2. Genital tract infections were common. Endocrine assessment demonstrated abnormalities of the pituitary-adrenal, pituitary-thyroid and pituitary-ovarian axes in seven women. One woman had panhypopituitarism. In six of the seven affected women CD4 counts were below 200 cells/mm3. Alterations in endocrine function were observed in seven of the women tested. While routine endocrine testing may not be indicated in all HIV-seropositive women, we should be aware of possible subtle presentations of endocrine abnormalities which may require treatment, especially in stress situations.

Weight reduction, fertility and contraception.

PIP: The significance of weight and body composition with regard to the fertile menstrual cycle has excited much interest. There is global imbalance of resources and problems of widespread chronic malnutrition in many 3rd world countries. This emphasizes the great importance of the possible effects of diet, body weight, and body composition on fecundity (ability to reproduce), fertility (reproductive performance), and pregnancy outcome. Frisch and Revelle suggested that a critical body weight is required for a girl to progress through puberty, menstruate, and finally develop ovulatory cycles. They postulated a direct relationship between weight and menarche and suggested that before menarche will occur at least 17% of the body weight needs to be made up of fat. The Frisch hypothesis is not universally accepted, and it seems highly unlikely that a single age unrelated body weight is always the trigger for menarche. Many of the data used in Frische's original studies were derived rather than directly observed. It seems likely that both body weight and composition are important and that the peripheral conversion of androgens to estrogens in fat plays a role in pubertal development, but the actual signal whcih triggers the hypothalamic events leading eventually through puberty to menstruation and ovulation remains unkown. Acute malnutrition, as seen during famine, is assoicated with a dramatic decrease in fertility. It is usually secondary to amenorrhea and annovulation. In developing countries weight related amenorrhea and delayed menarche are largely the result of nutritonal deprivation and the demands of lactation on women of boderline body weight, but a different pattern is seen in Western countries. The outstanding example of weight reduction resulting in infertility is seen in patients with anorexia nervosa. These women have extreme self imposed weight loss, a distorted perception of their body image, and disturbance in their attitude towards their feelings of hunger and satiety. Self imposed weight loss is the most common single cause of secondary amenorrhea seen in the Western world. While diagnosis of the gross anoretic is perhaps rarely missed, the more subtle degrees of weight loss and their effect on the menstrual cycle are often overlooked. Simple weight loss of more than 30% of body fat will cause menstrual dysfunction and ultimately amenorrhea. There is no clearly defined threshold between infertility and normal reproductive health, and there will always be women who become pregnant despite suboptimal weight. Patients with simple weight loss may be sufficiently motivated to restore their weight to normal levels, with resultant spontaneous resumption of ovulation.^ieng

The prevalence of antiphospholipid antibodies in women with reproductive failure or major abruptio placentae.

The so-called antiphospholipid syndrome may be responsible for repeated spontaneous abortion and fetal loss. We examined the plasma of 61 women with either reproductive failure or abruptio placentae for the presence of lupus anticoagulant and anticardiolipin antibodies in an attempt to assess the prevalence of this condition. No patient had haematological abnormalities consistent with the presence of lupus anticoagulant. However, 6 women had anticardiolipin antibodies with normal coagulation tests. The clinical profile together with this laboratory finding allows us to diagnose the antiphospholipid syndrome in these patients. Our incidence is considerably lower than that reported in many other studies but does suggest a place for screening for this condition in patients with recurrent complications of pregnancy.

Serum CA 125 concentrations in women with endometriosis or uterine fibroids treated with gonadotrophin-releasing hormone agonist analogues.

We assessed the possible role of CA 125 in the monitoring of gonadotrophin-releasing hormone (GnRH) agonist analogue therapy in women with endometriosis and uterine fibroids. Serum concentrations of this cell surface antigen did not correlate with uterine volume and appeared to have no value in the assessment of shrinkage of uterine fibroids during GnRH agonist treatment. While CA 125 levels were not always elevated in subjects with endometriosis, they fell during treatment in all patients. The change accurately reflected therapeutic progress in these women and was of particular value in those patients who had commenced therapy with elevated levels. It is suggested that CA 125 may be useful in the monitoring of therapeutic progress in selected patients with endometriosis treated with GnRH agonists; the need for surgical follow-up may be obviated.

'You are a man because you have children': experiences, reproductive health knowledge and treatment-seeking behaviour among men suffering from couple infertility in South Africa.

BACKGROUND: In Africa, infertility traditionally has been viewed as a female problem. This study explores reproductive health knowledge, health-seeking behaviour and experiences related to involuntary childlessness in men suffering from couple infertility. METHODS: Twenty-seven men from a diverse cultural urban community in South Africa participated in in-depth interviews at the time of their first visit to an infertility clinic in a tertiary referral centre. RESULTS: Men had little knowledge about the physiology of human fertility, causes of infertility and modern treatment options. Awareness of male factor infertility was, however, high. Most men appeared involved in the health-seeking process. Men described their emotional reactions to childlessness and the impact of infertility on marital stability, and many reported that infertile men suffered from stigmatization, verbal abuse and loss of social status. CONCLUSIONS: These findings improve our understanding of the reproductive health needs of men suffering from couple infertility in Africa. This understanding is essential for the effective integration of male partners into modern infertility management. The need for appropriate counselling of men and, most particularly, for education of the community is recognized.

Infertility in South Africa: women's reproductive health knowledge and treatment-seeking behaviour for involuntary childlessness.

BACKGROUND: Infertility is a major reproductive health problem in Africa. This paper presents the findings of two studies which focus on the knowledge that infertile women have about fertility and the causes of infertility, their treatment-seeking behaviour and their expectations of an infertility clinic. METHODS: A total of 150 infertile women from a culturally diverse, urban community in South Africa participated in the two studies. Both qualitative and quantitative research methods were applied using in-depth, semi-structured interviews and structured questionnaires. RESULTS: The women who participated had little knowledge about human reproduction and modern treatment options for infertility. They were highly motivated to find treatment and accessed both traditional and modern health care. Treatment barriers within modern health care were identified. CONCLUSIONS: The importance of health education and counselling is recognized, and both need to be integrated into infertility management, particularly in the developing world. The introduction of clinical guidelines is recommended in order to overcome treatment barriers and improve the delivery of health services.

'Men leave me as I cannot have children': women's experiences with involuntary childlessness.

BACKGROUND: This study explores the concerns and experiences related to involuntary childlessness of infertile women living in a diverse cultural urban community in South Africa. METHODS: In-depth interviews were conducted with 30 women seeking treatment for involuntary childlessness. Women were interviewed at the time of their first visit to an infertility clinic in a tertiary referral centre. RESULTS: All women verbalized intense emotions about their involuntary childlessness. In addition, a large number of women experienced negative social consequences including marital instability, stigmatization and abuse. CONCLUSIONS: These findings demonstrate that infertility can have a serious effect on both the psychological well-being and the social status of women in the developing world. Furthermore, the study provides insight into the cultural context of involuntary infertility in South Africa. The delivery of good infertility care in a community requires awareness of the implications of infertility and insight into the context in which these occur. Since many of the negative social implications of infertility are probably rooted in low status women in the developing world, effective intervention will ultimately require social, economical and political changes.