Optimisation of Follicular Recruitment in IVM Cycles (Elonva_IVM)

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

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 ?

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Uz Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elonva; A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.	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: 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.
Active Comparator: Puregon; Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.	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: 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.; Drug: Follitropin beta; Daily injection (three days) of follitropin beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of COC	Number of oocyte cumulus complexes obtained on the day of oocyte retrieval.	5 days after the first gonadotropin injection (on the day of oocyte retrieval)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Clinical pregnancy rate after the first embryo transfer following the IVM cycle	At about 6 - 7 weeks gestation

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Infertility; Infertility, Female; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Follicle Stimulating Hormone; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Desogestrel
• Other Study ID Numbers: 2017.corifollitropinalfa_IVM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No