Prospective open label, randomised, parallel group, comparative pilot.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
Gemeinschaftspraxis und Tagesklinik, Olpe 19
Dortmund, Germany
Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9
Heidelberg, Germany
Gemeinschaftspraxis und Tagesklinik, Zingel 29
Hildesheim, Germany
Royal Infirmary of Edinburgh, 51 Little France
Edinburgh, United Kingdom
Number of Participants With an Ongoing Pregnancy
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.
Time frame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test
Percentage of Participants With an Ongoing Pregnancy
Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.
Time frame: Approx week 13; 9 weeks or more after the first positive pregnancy test
Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters
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.
Time frame: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13)
Participants With Varying Numbers of Oocytes Retrieved
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.
Time frame: Approximately study day 15
Participants With Varying Numbers of Pronuclear Stage Oocytes
Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination.
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Leeds General Infirmary, Great George Street
Leeds, United Kingdom
The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk
Sheffield, United Kingdom
Time frame: Approximately study day 15
Participants With Varying Numbers of Embryos Transferred
Number of participants with various categories of numbers of embryos transferred.
Time frame: Approximately study day 17
Participants With Varying Numbers of Embryos Frozen
Number of participants with different categories of number of embryos frozen.
Time frame: Approximately study day 17
Mean Number of Days Stimulated With Gonadotrophins
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.
Time frame: study days 1 - 13
Pregnancy Outcomes
Long term follow-up to determine the outcome of the pregnancy.
Time frame: Approximately 10 months
Mean Endometrial Thickness
Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction.
Time frame: Day 7 or 9 or 11 or 13
Mean Estradiol Level
Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction.
Time frame: Day 7 or 9 or 11 or 13