Optimisation of Follicular Recruitment in IVM Cycles (Elonva_IVM)

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 3

Conditions: Polycystic Ovary Syndrome; Infertility, Female

Treatments: Procedure: transvaginal ultrasound scanning; Procedure: blood sampling; Drug: oral contraceptive pill pretreatment (Marvelon); Drug: Corifollitropin Alfa; Procedure: oocyte retrieval for IVM; Drug: Follitropin beta

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03197077

2017.corifollitropinalfa_IVM

Details and patient eligibility

About

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 ?

Enrollment: 145 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

Elonva

Experimental group

Description:

A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.

Treatment:

Drug: oral contraceptive pill pretreatment (Marvelon)

Procedure: blood sampling

Drug: Corifollitropin Alfa

Procedure: oocyte retrieval for IVM

Procedure: transvaginal ultrasound scanning

Puregon

Active Comparator group

Description:

Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.

Treatment:

Drug: oral contraceptive pill pretreatment (Marvelon)

Procedure: blood sampling

Procedure: oocyte retrieval for IVM

Procedure: transvaginal ultrasound scanning

Drug: Follitropin beta