Optimisation of Follicular Recruitment in IVM Cycles

Phase 3

Completed

• Conditions: Infertility, Female; Polycystic Ovary Syndrome
• Interventions: Procedure: blood sampling; Procedure: transvaginal ultrasound scanning; Procedure: oocyte retrieval for IVM; Drug: Corifollitropin Alfa; Drug: Follitropin beta; Drug: oral contraceptive pill pretreatment (Marvelon)

• Registration Number: NCT03197077
• Lead Sponsor: Universitair Ziekenhuis Brussel

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 ?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-23
• Study Start: 2017-11-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Puregon	blood sampling	Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
Puregon	transvaginal ultrasound scanning	Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
Elonva	oral contraceptive pill pretreatment (Marvelon)	A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
Elonva	transvaginal ultrasound scanning	A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
Elonva	oocyte retrieval for IVM	A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
Puregon	oocyte retrieval for IVM	Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
Elonva	blood sampling	A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
Puregon	oral contraceptive pill pretreatment (Marvelon)	Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
Elonva	Corifollitropin Alfa	A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
Puregon	Follitropin beta	Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Clinical pregnancy rate	At about 6 - 7 weeks gestation	Clinical pregnancy rate after the first embryo transfer following the IVM cycle

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussels, Belgium