A Retrospective Cohort Study Evaluating Surgical Aptitude Over Time in a New Male-To-Female Penoscrotal Vaginoplasty Program.

BACKGROUND: Given the burgeoning demand for gender affirmation surgery, there are few studies examining both surgical process variables and patient outcome variables. Knowing the learning curve for surgical teams who are beginning to perform this procedure will be important for patient safety and presurgical patient counseling as more institutions open transgender surgical programs. AIM: The purpose of this study was to determine the demographics of patients pursuing penoscrotal vaginoplasty, to determine their postoperative course, and to determine a learning curve for the surgical team performing penoscrotal vaginoplasty. METHODS: We retrospectively reviewed charts of all 43 patients who underwent penoscrotal vaginoplasty from the commencement of a new male-to-female penoscrotal vaginoplasty program in March 2018 through July 2019. OUTCOMES: Primary outcomes included mean hemoglobin decrease from surgery and operative time. Mean time to neoclitoral sensation, length of hospital admission, complication rates, reoperation rates, length of narcotic use after surgery, and demographics were also evaluated. Associations between surgical team experience and outcomes were assessed with Spearman's rho and Cox regression, and curve-fitting procedures were applied to determine the relationship. RESULTS: The mean operative time from initial incision to procedure finish was 225 minutes, and the mean decrease in hemoglobin was 3.3 g/dL. The mean time to neoclitoral sensation was 0.72 months. The time until neoclitoral sensation decreased as the surgical cases performed increased (Spearman's rho, -0.577 [P < .001]), with a power function best describing the learning curve. Operative time did not change with case number (Spearman's rho, 0.062 [P = .698]) but overall time in the operating room did (Spearman's rho, 0.631 [P < .001]). Mean length of hospital admission was 2.9 days. There were no intraoperative complications. 18 patients (42%) experienced a postoperative complication. 8 of 43 patients underwent reoperation (20%). Narcotics were used a mean of 9.5 days after surgery. CLINICAL IMPLICATIONS: A learning curve can be demonstrated in penoscrotal vaginoplasty for time to neoclitoral sensation and overall time in the operating room, plateauing between 30 and 40 cases. STRENGTHS AND LIMITATIONS: Strengths include assessing a learning curve for time to neoclitoral sensation, length of hospital stay, and length of postoperative narcotic use after penoscrotal vaginoplasty, which, to our knowledge, has not been reported elsewhere. Limitations include our overall low number of patients. CONCLUSION: Despite a low number of cases, length of hospital stay was short and the postoperative complication rate was similar to that of long-standing penoscrotal vaginoplasty programs. Whynott RM, Summers K, Mickelsen R, et al. A Retrospective Cohort Study Evaluating Surgical Aptitude Over Time in a New Male-To-Female Penoscrotal Vaginoplasty Program. J Sex Med 2020;17:1787-1794.

A Prospective Cohort Study to Evaluate the Impact of Diet, Exercise, and Lifestyle on Fertility: Design and Baseline Characteristics.

Diet, lifestyle, and psychosocial factors might influence fertility for men and women, although evidence is mixed, and couple-based approaches are needed for assessing associations with reproductive outcomes. The Impact of Diet, Exercise, and Lifestyle (IDEAL) on Fertility Study is a prospective cohort with contemporaneous detailed follow-up of female partners of men enrolled in the Folic Acid and Zinc Supplementation Trial studying couples seeking infertility treatment (2016-2019). Follow-up of men continued for 6 months, while female partners were followed for 9 months while attempting pregnancy and throughout any resulting pregnancy (up to 18 months). Longitudinal data on diet, physical activity (including measurement via wearable device), sleep, and stress were captured at multiple study visits during this follow-up. A subset of women (IDEALplus) also completed daily journals and a body fat assessment via dual-energy x-ray absorptiometry. IDEAL enrolled 920 women, and IDEALPlus enrolled 218. We demonstrated the ability to enroll women in a prospective cohort study contemporaneous to a partner-enrolled randomized trial. In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes. We describe in detail the study design, recruitment, data collection, lessons learned, and baseline characteristics.

Infertility and Health-Related Quality of Life in United States Women Veterans.

Background: To assess associations between infertility and health-related quality of life and medical comorbidities in U.S. women Veterans. Materials and Methods: This cross-sectional observational study involved computer-assisted telephone interviews of Veterans Administration-enrolled women between ages 21 and 52 years. Patients were analyzed in two groups by self-reported history of infertility. Outcomes included health-related quality of life as measured by the short-form 12-item interview (SF-12) physical and mental component summary (PCS and MCS) scores, depression, post-traumatic stress disorder (PTSD), eating disorders, fibromyalgia, other chronic pain, cardiovascular disease risk factors, and cancer. Age-adjusted p-values and adjusted odds ratios (AORs) were calculated using individual multivariate regression models to control for significant confounding covariates. Results: Of the 996 women veterans included, 179 (18.0%) reported a history of infertility. Infertility was associated with worse perceived physical health as determined by the SF-12 PCS [beta coefficient (B) -3.23 (-5.18 to -1.28)] and fibromyalgia [AOR 1.97 (1.22 to 3.19)]. Infertility was also associated with higher rates of depression, other chronic pain, and cancer, which remained significant after adjusting for age (p = 0.021, p = 0.016, and p = 0.045, respectively); however, no association for all was seen after adjustment for other significant covariates. There was no difference in Veterans' mental health using the SF-12 MCS, nor differences seen in PTSD or eating disorder rates, or in cardiovascular risk factors. Conclusions: This novel investigation in U.S. women Veterans found worse physical health-related quality of life and increased rates of fibromyalgia among women reporting a history of infertility, adding to the growing literature on infertility as a marker for overall poorer health.

A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome.

OBJECTIVE: To evaluate whether a combination of letrozole and clomiphene citrate (CC) results in higher ovulation rates than letrozole alone in infertile women with polycystic ovary syndrome (PCOS). DESIGN: Open-label randomized controlled trial. SETTING: Academic medical center using two clinic sites. PATIENT(S): Women 18-40 years of age with a diagnosis of infertility and PCOS as defined by the Rotterdam criteria and no other known cause of infertility. INTERVENTIONS(S): Participants were randomized in a 1:1 ratio, stratified by age and body mass index, to either 2.5 mg letrozole alone or the combination of 2.5 mg letrozole and 50 mg CC daily on cycle days 3-7 for one treatment cycle. MAIN OUTCOME MEASURE(S): Ovulation defined as mid-luteal serum progesterone concentration ≥3 ng/mL. RESULT(S): Seventy patients were randomized: 35 to letrozole alone and 35 to letrozole and CC. Results were analyzed according to the intention-to-treat principle. Women who received the combination of letrozole and CC had a statistically higher ovulation rate compared with those who received letrozole alone (27 of 35 women [77%] vs. 15 of 35 women [43%]). There were no serious adverse events or multiple-gestation pregnancies in either group. The side-effects profile was similar in the two treatment groups. CONCLUSION(S): The combination of letrozole and CC was associated with a higher ovulation rate compared with letrozole alone in women with infertility and PCOS. Further studies are needed to evaluate the effect on live birth rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT02802865.

Effect of body weight on early hormone levels in singleton pregnancies resulting in delivery after in vitro fertilization.

OBJECTIVE: To evaluate which clinical characteristics influence early maternal ß-human chorionic gonadotropin (hCG) and progesterone levels in in vitro fertilization (IVF) pregnancies. DESIGN: Retrospective cohort analysis. SETTING: Academic medical center. PATIENT(S): Women with a live birth after single-blastocyst embryo transfer in either a fresh or frozen cycle between 2004 and 2017, comprising 1,282 pregnancies in 1,057 patients. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): The initial human chorionic gonadotropin concentration (ß-hCG1) measured a mean of 10 days (range: 9-12 days) after embryo transfer, the rate of increase in ß-hCG concentrations, and progesterone concentration, with all analyses controlled for number of days between the embryo transfer and the ß-hCG1 measurement. RESULT(S): The clinical factor that positively influenced the ß-hCG1 level in the fresh cycle was the stimulation type (antagonist cycle higher than long agonist cycle). The clinical factors that negatively influenced both fresh and frozen cycle ß-hCG1 were lower embryo quality and increasing body weight. Increasing weight negatively impacted progesterone levels in both fresh and frozen cycles. A 100 lb (45.4 kg) difference in weight was associated with a 34.8% reduction in ß-hCG1 for both fresh and frozen cycle pregnancies. The rate of increase in ß-hCG was unaffected by body weight. A 100 lb (45.4 kg) difference in weight was associated with a 53.3% and a 32.8% reduction in progesterone in fresh and frozen cycles, respectively. CONCLUSION(S): Increasing body weight is associated with significantly lower ß-hCG and progesterone concentrations in early pregnancy after blastocyst single-embryo transfer in both fresh and frozen cycles. Clinicians should consider this when evaluating these hormone levels for prognostic and diagnostic purposes.

Fertility preservation training for obstetrics and gynecology fellows: a highly desired but non-standardized experience.

BACKGROUND: Despite a large body of data suggesting that delivery of fertility care to cancer patients is inconsistent and frequently insufficient, there is a paucity of literature examining training in fertility preservation for those physicians expected to discuss options or execute therapy. The study objective was to compare fertility preservation training between Reproductive Endocrinology & Infertility (REI) and Gynecologic Oncology (GYN ONC) fellows and assess the need for additional education in this field. METHODS: A 38-item survey was administered to REI and GYN ONC fellows in the United states in April 2014. Survey items included: 1) Clinical exposure, perceived quality of training, and self-reported knowledge in fertility preservation; 2) an educational needs assessment of desire for additional training in fertility preservation. RESULTS: Seventy-nine responses were received from 137 REI and 160 GYN ONC fellows (response rate 27%). REI fellows reported seeing significantly more fertility preservation patients and rated their training more favorably than GYN ONC fellows (48% of REI fellows versus 7% of GYN ONC fellows rated training as 'excellent', p < 0.001). A majority of all fellows felt discussing fertility preservation was 'very important' but fellows differed in self-reported ability to counsel patients, with 43% of REI fellows and only 4% of GYN ONC fellows able to counsel patients 'all the time' (p = 0.002). Seventy-six percent of all fellows felt more education in fertility preservation was required, and 91% felt it should be a required component of fellowship training. CONCLUSION: Significant variability exists in fertility preservation training for REI and GYN ONC fellows, with the greatest gap seen for GYN ONC fellows, both in perceived quality of fertility preservation training and number of fertility preservation patients seen. A majority of fellows in both disciplines support the idea of a standardized multi-disciplinary curriculum in fertility preservation.