Infertility, Female, Polycystic Ovary Syndrome
Conditions
Brief summary
The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries: 1. Early follicle recruitment in patients with polycystic ovaries using corifollitropin alfa: does administration of this drug result in earlier and higher FSH (follicle stimulating hormone) concentrations above the threshold for follicle recruitment in an IVM (in vitro maturation) cycle preceded by oral contraceptive suppression, in comparison to normal daily administration of rFSH (recombinant follicle stimulating hormone, Puregon)?; 2. The maturation rate of the obtained oocyte-cumulus complexes in standard IVM media registered for clinical use: does stimulation with corifollitropin alfa versus recombinant FSH have an impact on the maturation rate and developmental capacity of the oocytes ?
Interventions
PROCEDUREblood sampling
comparison between corifollitropin alfa and follitropin beta in IVM cycles
PROCEDUREtransvaginal ultrasound scanning
comparison between corifollitropin alfa and follitropin beta in IVM cycles
PROCEDUREoocyte retrieval for IVM
comparison between corifollitropin alfa and follitropin beta in IVM cycles
DRUGCorifollitropin Alfa
Single injection of 100 micrograms of corifollitropin alfa
DRUGFollitropin beta
Daily injection (three days) of follitropin beta
DRUGoral contraceptive pill pretreatment (Marvelon)
Daily administration of the oral contraceptive pill (Marvelon) for 21 days. Administration of the combined oral contraceptive pill will start after a blood test that demonstrates basal E2 levels and a negative serum hCG level.
Sponsors
Merck Sharp & Dohme LLC
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
Inclusion criteria
1. Subfertile patients between 18-36 years old eligible for ART treatment 2. BMI 18-30 3. Polycystic ovaries (PCO) according to the Rotterdam criteria (at least 12 antral follicles per ovary as observed on a baseline ultrasound scan), with or without hyperandrogenism, with or without oligoamenorrhoea. In other words, patients are eligible if they have PCO morphology. A diagnosis of PCOS (polycystic ovary syndrome) based on Rotterdam criteria is not compulsory.
Exclusion criteria
1. Antral follicle count (AFC) \<24 2. Anti-müllerian hormone (AMH) \<3,25 in non-OCP (oral contraceptive pill) users and \<4,00 in current OCP users (using Elecsys platform (Roche Diagnostics)) 3. Couples requesting PGD (preimplantation genetic diagnosis) 4. Non-obstructive azoospermia in the male partner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of COC | 5 days after the first gonadotropin injection (on the day of oocyte retrieval) | Number of oocyte cumulus complexes obtained on the day of oocyte retrieval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | At about 6 - 7 weeks gestation | Clinical pregnancy rate after the first embryo transfer following the IVM cycle |
Countries
Belgium
Outcome results
None listed