Status
Completed
Phase
Phase 3
Enrollment
71
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients. Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio Patients: Oocyte donors (aged 18-36 years) Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger. Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) \> 10 IU/L, till day of trigger. Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.
Interventions
COMBINATION_PRODUCT
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH \> 10 IU/L, till day of trigger.
COMBINATION_PRODUCT
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Timeline
First posted
Dec 6, 2018
Study start
Nov 1, 2018
Primary completion
May 27, 2022
Study completion
Nov 25, 2022
Results posted
Not reported
Registry updated
May 16, 2023
Outcomes
total amount of COC (cumulus-oocyte-complex)
Time frame · at oocyte aspiration
Endocrine profile
Time frame · 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
LH (Luteinising hormone) level
Endocrine profile
Time frame · 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
FSH level
Endocrine profile
Time frame · 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
Progesterone level
Endocrine profile
Time frame · 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
Estradiol level
Consumption of gonadotrophins
Time frame · during the ovarian stimulation
totaal amount of IU (international units) used
Number of days needed for ovarian stimulation
Time frame · during the ovarian stimulation
Days of GnRH antagonist use
Time frame · during the ovarian stimulation
Total number of mature oocytes
Time frame · at day of oocyte aspiration
Total medication cost
Time frame · during the ovarian stimulation
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
Study locations
Belgium. Showing up to 24 locations stored in the fast local snapshot.
Universitair Ziekenhuis Brussel
Brussels, Belgium
Publications
No PMID-linked publications were present in this registry snapshot.
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