Clinical trial NCT03767218: Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase
Official title: Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility, Female
Keywords: Oocyte donor
Ovarian stimulation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: total amount of COC (cumulus-oocyte-complex)
timeFrame: at oocyte aspiration
Secondary outcomes:
measure: Endocrine profile
timeFrame: 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
measure: Endocrine profile
timeFrame: 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
measure: Endocrine profile
timeFrame: 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
measure: Endocrine profile
timeFrame: 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
measure: Consumption of gonadotrophins
timeFrame: during the ovarian stimulation
measure: Number of days needed for ovarian stimulation
timeFrame: during the ovarian stimulation
measure: Days of GnRH antagonist use
timeFrame: during the ovarian stimulation
measure: Total number of mature oocytes
timeFrame: at day of oocyte aspiration
measure: Total medication cost
timeFrame: during the ovarian stimulation
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References: