Infertility, Female Clinical Trial
Official title:
Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.
Verified date | April 2022 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.
Status | Completed |
Enrollment | 71 |
Est. completion date | November 25, 2022 |
Est. primary completion date | May 27, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility | Inclusion Criteria: - oocyte donor patients - Age from 18 to 36 years - BMI 19 to 35 - Regular menstrual cycle length i.e. 24-35 days Exclusion Criteria: - Patients with AMH <1.1 ng/ml and/or AFC<7 - Patients with FNPO (Follicle Number Per Ovary) = 19 and/ord AMH >5ng/ml - Endometriosis grade 3-4 - Oligo-amenorrhea - Any untreated endocrine abnormality |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Brussel |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total amount of COC (cumulus-oocyte-complex) | at oocyte aspiration | ||
Secondary | Endocrine profile | LH (Luteinising hormone) level | on menstrual cycle day 2 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | |
Secondary | Endocrine profile | FSH level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | |
Secondary | Endocrine profile | Progesterone level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | |
Secondary | Endocrine profile | Estradiol level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | |
Secondary | Consumption of gonadotrophins | totaal amount of IU (international units) used | during the ovarian stimulation | |
Secondary | Number of days needed for ovarian stimulation | during the ovarian stimulation | ||
Secondary | Days of GnRH antagonist use | during the ovarian stimulation | ||
Secondary | Total number of mature oocytes | at day of oocyte aspiration | ||
Secondary | Total medication cost | during the ovarian stimulation |
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