NCT03197077

Optimisation of Follicular Recruitment in IVM Cycles

A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 36 Years
• Healthy volunteers: Not accepted

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 ?

Conditions

• Infertility, Female
• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
PROCEDURE	blood sampling	comparison between corifollitropin alfa and follitropin beta in IVM cycles
PROCEDURE	transvaginal ultrasound scanning	comparison between corifollitropin alfa and follitropin beta in IVM cycles
PROCEDURE	oocyte retrieval for IVM	comparison between corifollitropin alfa and follitropin beta in IVM cycles
DRUG	Corifollitropin Alfa	Single injection of 100 micrograms of corifollitropin alfa
DRUG	Follitropin beta	Daily injection (three days) of follitropin beta
DRUG	oral 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.

Timeline

• Start date: 2017-11-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-06-23
• Last updated: 2023-04-07

Locations

1 site across 1 country: Belgium