Towards more patient-centred endometriosis care: a cross-sectional survey using the ENDOCARE questionnaire.

STUDY QUESTION: What is the performance of the patient-centredness of endometriosis care in a secondary and a tertiary care setting and how can it be improved? SUMMARY ANSWER: Overall, patient-centredness was comparable in the two endometriosis care centres, but differed regarding 'physical comfort' and 'continuity and transition'; both centres can learn how to improve several of their targets from the other's strengths. WHAT IS KNOWN ALREADY: The ENDOCARE questionnaire (ECQ) is a validated questionnaire for assessing the important quality dimension 'patient-centredness'. Patient-centredness is associated with quality of life, although this should be explored further by larger-scale studies. STUDY DESIGN SIZE DURATION: A cross-sectional survey, relying on the ECQ, was performed (during 2015 and 2016) among 407 women with surgically diagnosed endometriosis. PARTICIPANTS/MATERIALS SETTING METHODS: This study was conducted in a secondary and a tertiary care centre in the Netherlands. A total of 209 Dutch-speaking women who had endometriosis surgery (2013-2014), completed the ECQ after a postal invitation and, if needed, postal reminders. The assessed outcomes were: overall patient-centredness, the patient-centredness for each of its 10 dimensions, and the patient-centred strengths and targets for improvement. Case-mix adjusted patient-centredness scores (PCS) were compared and strengths and targets for improvement were identified with a matrix modelling importance against experience. The need to improve the targets was quantified with quality impact indices. MAIN RESULTS AND THE ROLE OF CHANCE: No difference was demonstrated between the overall PCS of the secondary and tertiary centres (respectively: 4.8 and 4.5; P = 0.15). No difference was found in PCS per dimension between the two clinics except for the secondary care centre performing better regarding 'physical comfort' (respectively: 4.5 and 3.0; P = 0.01) and 'continuity and transition' (respectively: 6.0 and 4.2; P = 0.01). The two centres had nine targets for improvement in common. The secondary and tertiary centres, respectively, had five and seven additional centre-specific targets for improvement. Cross-centre learning is encouraged as 9 out the 12 additional centre-specific targets were strengths in the other centre. The main improvement targets were being able to contact the centre in case of emergency (both centres), the involvement of a significant other (secondary centre), diagnostic delay (secondary centre), personal follow-up (tertiary centre) and disclosing the level of competence of healthcare providers (tertiary centre). LIMITATIONS REASON FOR CAUTION: Responders did not differ from non-responders in their stage of endometriosis, educational level, rating of endometriosis care and degree to which their complaints are suppressed. Endometriosis is a chronic condition and patient-centredness might be experienced differently at other points of the endometriosis care trajectory. WIDER IMPLICATION OF THE FINDINGS: The ECQ is a useful tool to assess patient-centredness in both secondary and tertiary care centres. Further research should focus on how to improve endometriosis care. STUDY FUNDING/COMPETING INTERESTS: No external funding was used. V.M. and C.B.L. report grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication.

The capacity of transvaginal hydrolaparoscopy versus hysterosalpingography to diagnose tubal pathology in the work-up of subfertile women, a randomised clinical trial.

OBJECTIVE: To assess the capacity of transvaginal hydrolaparoscopy (THL) versus hysterosalpingography (HSG) as a primary tool to diagnose tubal pathology. STUDY DESIGN: We performed a multicenter RCT (NTR3462) in 4 teaching hospitals in the Netherlands, comparing THL and HSG as first line tubal test in subfertile women. The primary outcome of the trial was cumulative live birth rate at 24 months. Here, we present the secondary outcomes, the diagnostic findings of both THL and HSG as well as performance defined as failures, complications and pain- and acceptability scores. RESULTS: Between May 2013 and October 2016, we allocated 149 women to THL and 151 to HSG, of which 17 women in the THL group (11.4%) and 12 in the HSG group (7.9%) conceived naturally before the scheduled procedure, while 13 HSGs and 5 THLs were not performed for other reasons (withdrawal of informed consent, not willing to undergo tubal testing and protocol violations). A total of 119 THLs and 134 HSGs were carried out. Failures were seen more in the THL group (n = 8, 5.6%) than in the HSG group (n = 1, 0.7%) (p = 0.014). Complications did not differ significantly between the groups (THL n = 4; 2.8% vs HSG n = 1; 0.7%) (p = 0.20). Bilateral tubal occlusion was detected in one versus three women (0.9% versus 2.2%) of the THL group and HSG group, while unilateral tubal occlusion was detected in seven (6.2%) versus eight (5.9%) women, respectively. Normal findings were seen in 96 (79.3%) women randomised to THL and in 119 (87.5%) in women randomised for HSG (RR 0.91 95%CI 0.81-1.01, p = 0.08). The pain score was significantly less for THL (VAS 4.7 (SD: 2.5)) than for HSG (VAS 5.4 (SD:2.5)) (p 0.038). The acceptability rate of THL and was high and comparable. CONCLUSION: THL and HSG have a comparable capacity in diagnosing tubal pathology with comparable performance in safety, pain and acceptability.

Performance of outpatient transvaginal hydrolaparoscopy.

STUDY QUESTION: What is the feasibility of performing transvaginal hydrolaparoscopy (THL) in an outpatient setting? SUMMARY ANSWER: It is feasible to perform THL in an outpatient setting, reflected by a low complication and failure rate and a high patients' satisfaction. WHAT IS KNOWN ALREADY: THL is a safe method to investigate tubal patency and exploring the pelvis in subfertile women. STUDY DESIGN, SIZE, DURATION: Retrospective cohort study of 1127 subfertile women who underwent THL as primary diagnostic method for testing tubal patency in an outpatient setting. PARTICIPANTS/MATERIALS, SETTING, METHODS: We studied all THL procedures performed as a primary diagnostic tubal patency test in an outpatient setting in subfertile women starting from the initial THL in four large hospitals. Baseline characteristics were obtained, as well as the outcome of the procedures in terms of success, complications and findings by examining medical records. We used a uniform visual analogue scale (VAS) score document to collect data on pain and acceptability prospectively and compared two methods of pain relief. MAIN RESULTS AND THE ROLE OF CHANCE: We studied a total of 1103 women who underwent THL. Successful access to the pouch of Douglas was achieved in 1028 women (93.2%), and 1017 women had a complete evaluation (92.2%). Double-sided tubal patency was found in 844 women (83%), unilateral tubal patency in 127 women (12.5%), while in 46 women (4.5%) bilateral occluded tubes were diagnosed. Endometriosis alone was seen in 64 women (6.3%), adhesions alone in 87 women (8.6%) and both endometriosis and adhesions in 42 women (4.1%).Complications occurred in 29 (2.6%) women, including 10 perforations of the rectum (0.9%), 8 perforations of the posterior uterine wall (0.7%) and 5 infections/pelvic inflammatory diseases (PIDs) (0.5%). Bleeding of the vaginal wall requiring intervention and hospital admissions due to pain was seen in 4 (0.4%) and 2 women, respectively (0.2%). The average pain score was rated 4.0 (±2.4 SD) on a VAS from 0 to 10 with 0 meaning no pain at all with no difference in different types of pain relief. Acceptability was rated 1.5 (±2.1 SD). LIMITATIONS, REASONS FOR CAUTION: The main limitation of the study is its retrospective character and the fact that only a fourth of the women were asked for pain and acceptability scores. WIDER IMPLICATIONS OF THE FINDINGS: THL can be used as a primary method for tubal assessment in an outpatient setting. Further randomized studies are needed to assess whether THL is superior to other methods and strategies for tubal assessment in terms of prognostic capacity and cost-effectiveness. STUDY FUNDING/COMPETING INTEREST: No external funding was either sought or obtained for this study. The authors have no competing interests to declare.

The HysNiche trial: hysteroscopic resection of uterine caesarean scar defect (niche) in patients with abnormal bleeding, a randomised controlled trial.

BACKGROUND: A caesarean section (CS) can cause a defect or disruption of the myometrium at the site of the uterine scar, called a niche. In recent years, an association between a niche and postmenstrual spotting after a CS has been demonstrated. Hysteroscopic resection of these niches is thought to reduce spotting and menstrual pain. However, there are no randomised trials assessing the effectiveness of a hysteroscopic niche resection. METHODS/DESIGN: We planned a multicentre randomised trial comparing hysteroscopic niche resection to no intervention. We study women with postmenstrual spotting after a CS and a niche with a residual myometrium of at least 3 mm during sonohysterography. After informed consent is obtained, eligible women will be randomly allocated to hysteroscopic resection of the niche or expectant management for 6 months. The primary outcome is the number of days with postmenstrual spotting during one menstrual cycle 6 months after randomisation. Secondary outcomes are menstrual characteristics, menstruation related pain and experienced discomfort due to spotting or menstrual pain, quality of life, patient satisfaction, sexual function, urological symptoms, medical consultations, medication use, complications, lost productivity and medical costs. Measurements will be performed at baseline and at 3 and 6 months after randomisation. A cost-effectiveness analysis will be performed from a societal perspective at 6 months after randomisation. DISCUSSION: This trial will provide insight in the (cost)effectiveness of hysteroscopic resection of a niche versus expectant management in women who have postmenstrual spotting and a niche with sufficient residual myometrium to perform a hysteroscopic niche resection. TRIAL REGISTRATION: Dutch Trial Register NTR3269 . Registered 1 February 2012. ZonMw Grant number 80-82305-97-12030.

Recombinant LH supplementation to a standard GnRH antagonist protocol in women of 35 years or older undergoing IVF/ICSI: a randomized controlled multicentre study.

STUDY QUESTION: Does the addition of exogenous LH to an IVF/ICSI stimulation protocol with recombinant FSH (r-FSH) and a GnRH antagonist improve the ovarian response and pregnancy rates in women of 35 years and older? SUMMARY ANSWER: Supplementation of LH during the second half of the follicular phase has no effect on pregnancy rates, implantation rates or on ovarian response in women of 35 years and older undergoing GnRH antagonist IVF/ICSI cycles. WHAT IS KNOWN ALREADY: In IVF/ICSI stimulation protocols GnRH agonists or antagonists are administered to prevent a premature pituitary LH surge, which can have a detrimental effect on the IVF/ICSI procedure. In effect, GnRH analogues cause the levels of both gonadotrophins to drop. In order to allow follicle growth FSH is administered exogenously, whereas LH is usually not supplemented. Although GnRH analogues prevent LH surges, there is evidence that, particularly in older women, administration of GnRH analogues may cause endogenous LH levels to decrease excessively. Several studies have been performed to investigate whether the addition of recombinant LH (r-LH) to r-FSH improves cycle outcome. Only a few studies have analysed this issue in the GnRH antagonist protocol and the results of these trials obtained in older women (>35 years old) are conflicting. STUDY DESIGN, SIZE, DURATION: A multicentre RCT was performed between 2004 and 2010 in 253 couples who were undergoing IVF or ICSI. Women were 35 years or older and received ovarian stimulation in a protocol with r-FSH (Gonal-F 225 IU/day) starting from cycle day 3 and GnRH antagonist (Cetrotide 0.25 mg/day) from stimulation day 6. Randomization took place on stimulation day 6 to receive both r-FSH and r-LH (Luveris 150 IU/day) or continue with FSH alone. Randomization for r-LH supplementation was performed centrally by serially numbered, opaque, sealed envelopes, stratified by centre. PARTICIPANTS/MATERIALS, SETTING, METHODS: Of 253 subjects randomized, 125 received both r-FSH and r-LH and 128 received r-FSH only. Patients were recruited from the Division of Reproductive Medicine of the Obstetrics and Gynaecology department of four hospitals in the Netherlands. MAIN RESULTS AND THE ROLE OF CHANCE: There were no demographic or clinical differences between the groups. The intention-to-treat analysis revealed that of those receiving both r-FSH and r-LH, 35 (28.0%) had a clinical pregnancy, compared with 38 (29.7%) receiving only r-FSH (mean difference -1.5%; 95% confidence interval (CI) -9.4 to 12.7, P = 0.9). Ongoing pregnancy rates were 25 (20%) versus 28 (21.9%) (mean difference -1.9%; 95% CI -8.2 to 11.9, P = 0.9) and implantation rates 18.8 versus 20.7% (mean difference -1.9%; 95% CI -8.0 to 11.7, P = 0.6) in the 'r-FSH and r-LH' and 'r-FSH only' groups respectively. LIMITATIONS, REASONS FOR CAUTION: A limitation of our study is its early closure. This was done because the interim analysis after randomization of 250 patients indicated no benefit in any aspect of the experiment. WIDER IMPLICATIONS OF THE FINDINGS: Given previous data, including a Cochrane review, and our own results the evidence indicates that LH supplementation has no benefit on ongoing pregnancy rates in women of 35 years or older. STUDY FUNDING/COMPETING INTEREST(S): Merck Serono Netherlands, an affiliate of Merck Serono SA- Geneva, an affiliate of Merck KGaA, Darmstadt, Germany has donated the r-LH (Luveris(®)). No conflict of interest to declare. TRIAL REGISTRATION NUMBER: The trial was registered in the Dutch trial register (ISRCTN10841210).

The influence of maternal and paternal factors on time to pregnancy--a Dutch population-based birth-cohort study: the GECKO Drenthe study.

BACKGROUND: Both maternal and paternal factors have been suggested to influence a couple's fecundity. To investigate this, we examined the role of several maternal and paternal lifestyle and socio-demographic factors as determinants of time to pregnancy (TTP) in a Dutch birth-cohort. METHODS: Groningen Expert Center for Kids with Obesity (GECKO) Drenthe is a population-based birth-cohort study of children born between April 2006 and April 2007 in Drenthe, a province of The Netherlands. Both partners received extensive questionnaires during pregnancy. Univariable and multivariable Cox regression analyses were used to determine the impact of the investigated factors on TTP. RESULTS: A total of 4778 children were born, and the parents of 2997 children (63%) gave their consent to participate. After excluding unintended pregnancies and pregnancies as a result of fertility treatment, the data of 1924 couples were available for analysis. Hazards ratios and 95% confidence intervals of factors influencing TTP in multivariable Cox regression analysis were: maternal age 1.23 (0.98-1.54) for age <25 years, 1.17 (1.03-1.32) for age 25-30 years and 0.72 (0.61-0.85) for age >35 years (reference category: 30-35 years); paternal age: 1.31 (0.94-1.82) for age <25 years, 1.11 (0.97-1.28) for age 25-30 years and 0.91 (0.80-1.04 for age >35 years (reference category: 30-35 years); nulliparity: 0.76 (0.68-0.85) versus multiparity; menstrual cycle length: 1.12 (0.95-1.30) for 3 weeks, 0.72 (0.62-0.83) for 4-6 weeks, 0.68 (0.40-1.16) for >6 weeks and 0.66 (0.54-0.81) for irregular cycle (reference category: 4 weeks); prior contraceptive use: 0.78 (0.67-0.91) for no contraception, 1.68 (1.45-1.95) for condom use, 1.08 (0.89-1.33) for condom use combined with oral contraception, 1.40 (1.16-1.70) for intrauterine device and 0.50 (0.25-1.01) for contraceptive injection (reference category: oral contraception); and maternal educational level 0.75 (0.62-0.92) for low education level and 0.81 (0.73-0.90) for medium educational level (reference category: high educational level). CONCLUSIONS: This population-based birth-cohort study performed in fertile couples who had conceived revealed neither maternal nor paternal modifiable lifestyle factors were significantly associated with TTP after adjustment for confounding by socio-demographic factors. In contrast, several non-modifiable maternal socio-demographic factors are significant predictors of a couple's fecundity.