An eight centre, retrospective, clinical practice data analysis of algorithm-based treatment with follitropin delta.

RESEARCH QUESTION: Can efficacy and success rates of the first recombinant FSH expressed in a human cell line with an individualized dosing algorithm based on body weight and anti-Müllerian hormone (AMH) as shown in the ESTHER-1 trial be confirmed in routine clinical practice? DESIGN: In eight reproductive medicine centres in Germany, observational data of 360 women who underwent ovarian stimulation with follitropin delta were evaluated as part of the quality control from January 2018 to June 2019. The data were analysed retrospectively. RESULTS: Mean age of patients was 33.5 (±3.8) years. Pretreatment AMH concentrations ranged from <0.5 ng/ml or 3.6 pmol/l (2.5%) to >5.6 ng/ml or 40 pmol/l (19.7%), with 79.7% of all AMH measurements above 2.0 ng/ml or 14.5 pmol/l. The mean number of oocytes obtained in n = 359 first follitropin delta cycles was 11.2 (±6.7) oocytes with 42.1% of patients having between eight and 14 oocytes retrieved at oocyte retrieval. The average clinical pregnancy rate in the first cycle with a fresh embryo transfer was 38.2% with a mean of 1.4 embryos per transfer. The cumulative pregnancy rate was 49.4% for the first stimulation cycle (including cryopreservation cycles generated from the first stimulation cycle). CONCLUSION: The goal of obtaining an adequate number of oocytes (8-14 oocytes) using the follitropin delta dosing algorithm was reached in 42.1% of patients despite a wide range of pretreatment AMH values, while achieving very good clinical pregnancy rates. Hence, algorithm-based ovarian stimulation with follitropin delta remains highly effective in clinical practice.

Smoking is associated with increased free testosterone and fasting insulin levels in women with polycystic ovary syndrome, resulting in aggravated insulin resistance.

OBJECTIVE: To evaluate the impact of smoking on endocrine, metabolic, and clinical parameters in women with polycystic ovary syndrome (PCOS). DESIGN: Cohort analysis. SETTING: University hospital. PATIENT(S): 346 women with PCOS, including 98 smokers and 248 nonsmokers. INTERVENTION(S): Screening panel, including physical examination, weight and height measurement, and ultrasound examination of the ovaries, and hormone and insulin measurements. MAIN OUTCOME MEASURE(S): Clinical, metabolic, and endocrine parameters, oral glucose tolerance test, calculation of insulin resistance indexes. RESULT(S): In women with PCOS, smoking was associated with statistically significantly increased levels of fasting insulin and calculated free testosterone (cFT) and with a raised free androgen index (FAI) score, which resulted in aggravated scores on the homeostatic model for assessment of insulin resistance (HOMA-IR). However, no differences were observed between the smoking and nonsmoking groups with regard to the clinical parameters for hirsutism, acne, ovulatory function (classified as eumenorrhea, oligomenorrhea, and amenorrhea), or polycystic ovaries using the ultrasound criteria recommended according to the Rotterdam definition. CONCLUSION(S): In women with PCOS, smoking is associated with increased free testosterone and fasting insulin levels, resulting in aggravated insulin resistance. However, there were no differences between smokers and nonsmokers when clinical parameters were compared.