Subcutaneously administered Menopur, a new highly purified human menopausal gonadotropin, causes significantly fewer injection site reactions than Repronex in subjects undergoing in vitro fertilization.

BACKGROUND: The safety and tolerability of a new highly purified, urine-derived human menopausal gonadotropin (hMG) preparation [Menopur] was compared with a currently available hMG [Repronex] in women undergoing in vitro fertilization (IVF). METHODS: This was a randomized, open-label, parallel-group, multicenter study conducted in subjects undergoing IVF. Women (N = 125), 18-39 years of age, underwent pituitary down-regulation with leuprolide acetate beginning 7 days prior to onset of menses and continuing up to the day before hCG administration. Subjects were randomized to receive subcutaneous (SC) Menopur (n = 61) or Repronex SC (n = 64) for a maximum of 12 days. All adverse events (AEs) were recorded and subject self-assessments of injection site reactions were recorded in a daily diary. RESULTS: Significantly fewer subjects in the Menopur group reported injection site reactions (P < 0.001) compared to the Repronex group. Overall, there was no statistically significant difference in the incidence of AEs between the two treatment groups. CONCLUSION: Menopur SC offers a greater safety and tolerability profile compared to Repronex SC.

A Markov model of the cost-effectiveness of human-derived follicle-stimulating hormone (FSH) versus recombinant FSH using comparative clinical trial data.

This study compared the cost and effectiveness of highly purified, human-derived follicle-stimulating hormone (FSH) (Bravelle) to recombinant FSH (Follistim) using Markov modeling and Monte Carlo simulation. One IVF treatment cycle resulted in costs of 11,584 dollars +/- 211 dollars for human-derived FSH and 12,762 dollars +/- 170 dollars for recombinant FSH, while three treatment cycles, holding the transition probabilities of the first cycle constant for the next two cycles, resulted in costs of 22,712 dollars +/- 1,107 dollars for human-derived FSH and 24,935 dollars +/- 1,205 dollars for recombinant FSH.

A survey of the practices and opinions of the domestic members of the American Society for Reproductive Medicine.

OBJECTIVE: To learn how the domestic members of the American Society for Reproductive Medicine (ASRM) use its services and to survey their opinions regarding clinical practices and research in reproductive medicine. DESIGN: A self-administered mail survey. SETTING: Members of a professional organization. SUBJECT(S): A total of 1,291 members responded. Of these, 80% were physicians, embryologists, or nurses. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Demographics, use of ASRM services, and opinions. RESULT(S): Eighty-five percent of the respondents provided some type of clinical care for individuals with fertility problems. Two thirds read the ASRM News, and more than half used ASRM Practice Committee statements, Ethics Committee opinions, and patient education materials. Eighty-three percent reported that they followed the Ethics Committee opinions. Whereas 78% did not support reproductive cloning, two thirds supported somatic cell nuclear transfer to produce stem cells for research. The majority opposed governmental regulation of assisted reproductive technologies. CONCLUSION(S): The domestic membership of the ASRM is diverse in terms of demographics, practices, and opinions. In addition, they find the services of the ASRM to be of value.

American Society for Reproductive Medicine: reaching its full potential.

The domestic members of the American Society for Reproductive Medicine have voiced their opinions and beliefs about the Society and contemporary issues in reproductive medicine.

Evaluation of mixed protocols with Bravelle (human-derived FSH) and Repronex (hMG) to assess clinical efficacy (EMBRACE) in women undergoing in vitro fertilization.

OBJECTIVE: To compare the efficacy and safety of three different ratios of human-derived follicle-stimulating hormone/human menopausal gonadotropin (human-derived FSH:hMG, Bravelle and Repronex) mixed together in the same syringe and administered subcutaneously once daily, to in vitro fertilization (IVF) patients <34 years or 34 to 40 years of age. DESIGN: Two randomized, prospective, age stratified, IVF studies. SETTING: Twenty-one academic and private clinics with experience in IVF/embryo transfer (ET). PATIENT(S): Infertile premenopausal women undergoing IVF-ET. INTERVENTION(S): Pituitary suppression with leuprolide acetate, randomization to one of three treatment groups, followed by gonadotropin stimulation (GS) for up to 15 days. The human-derived FSH:hMG ratios were the following: Group 1, a 1:1 ratio throughout; Group 2, a 3:0 ratio that was changed to 1:1 after GS day 5; Group 3, a 2:1 ratio that was increased to 3:1, 4:1, or 5:1 after GS day 5, as needed. MAIN OUTCOME MEASURE(S): Mean number of oocytes retrieved; peak estradiol levels; dose and duration of stimulation; implantation rates; adverse events; injection site pain; and pregnancy and live birth rates. RESULT(S): Overall, women <34 years had higher E(2) levels, more oocytes retrieved, and improved implantation and live birth rates compared with women 34 to 40 years old. Nonetheless, each ratio of human-derived FSH:hMG produced comparable implantation rates, and continuing pregnancy and take-home baby rates. CONCLUSION(S): All three ratios of human-derived FSH:hMG in both age groups produced comparable pregnancy and live birth rates with similar safety results.