Optimisation of Follicular Recruitment in IVM Cycles

NCT03197077 | Completed Phase 3

• 1 other identifier: 2017.corifollitropinalfa_IVM
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The study will focus on important aspects related to follicle recruitment using exogenous gonadotropins in patients with polycystic ovaries:

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical pregnancy rate

  At about 6 - 7 weeks gestation

Study Arms (2)

Elonva

EXPERIMENTAL

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

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

Puregon

ACTIVE COMPARATOR

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

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

Interventions

blood sampling PROCEDURE

comparison between corifollitropin alfa and follitropin beta in IVM cycles

Elonva; Puregon

transvaginal ultrasound scanning PROCEDURE

comparison between corifollitropin alfa and follitropin beta in IVM cycles

Elonva; Puregon

oocyte retrieval for IVM PROCEDURE

comparison between corifollitropin alfa and follitropin beta in IVM cycles

Elonva; Puregon

Corifollitropin Alfa DRUG

Single injection of 100 micrograms of corifollitropin alfa

Elonva

Follitropin beta DRUG

Daily injection (three days) of follitropin beta

Puregon

oral contraceptive pill pretreatment (Marvelon) DRUG

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.

Elonva; Puregon

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subfertile patients between 18-36 years old eligible for ART treatment
• BMI 18-30
• 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.

You may not qualify if:

• Antral follicle count (AFC) \<24
• 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))
• Couples requesting PGD (preimplantation genetic diagnosis)
• Non-obstructive azoospermia in the male partner

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome

Interventions

Blood Specimen Collection; Oocyte Retrieval; Intravital Microscopy; follicle stimulating hormone, human, with HCG C-terminal peptide; follitropin beta; Contraceptives, Oral; Desogestrel

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Microscopy; Diagnostic Imaging; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 23, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)