A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa
- Registration Number
- NCT00257556
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Prospective open label, randomised, parallel group, comparative pilot.
- Detailed Description
Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Menotrophin Menotrophin - Follitropin alfa Follitropin alfa -
- Primary Outcome Measures
Name Time Method Number of Participants With an Ongoing Pregnancy Approx week 13; 9 weeks or more after the 1st positive pregnancy test Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.
Percentage of Participants With an Ongoing Pregnancy Approx week 13; 9 weeks or more after the first positive pregnancy test Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.
- Secondary Outcome Measures
Name Time Method Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met.
Participants With Varying Numbers of Oocytes Retrieved Approximately study day 15 Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with \>= 17mm in diameter.
Participants With Varying Numbers of Pronuclear Stage Oocytes Approximately study day 15 Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.
Participants With Varying Numbers of Embryos Transferred Approximately study day 17 Number of participants with various categories of numbers of embryos transferred.
Participants With Varying Numbers of Embryos Frozen Approximately study day 17 Number of participants with different categories of number of embryos frozen.
Mean Number of Days Stimulated With Gonadotrophins study days 1 - 13 Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination.
Pregnancy Outcomes Approximately 10 months Long term follow-up to determine the outcome of the pregnancy.
Mean Endometrial Thickness Day 7 or 9 or 11 or 13 Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.
Mean Estradiol Level Day 7 or 9 or 11 or 13 Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.
Trial Locations
- Locations (6)
The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk
🇬🇧Sheffield, United Kingdom
Leeds General Infirmary, Great George Street
🇬🇧Leeds, United Kingdom
Gemeinschaftspraxis und Tagesklinik, Zingel 29
🇩🇪Hildesheim, Germany
Royal Infirmary of Edinburgh, 51 Little France
🇬🇧Edinburgh, United Kingdom
Gemeinschaftspraxis und Tagesklinik, Olpe 19
🇩🇪Dortmund, Germany
Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9
🇩🇪Heidelberg, Germany