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NCT Number: NCT03197077

Optimisation of Follicular Recruitment in IVM Cycles

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 ?

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Key information

Conditions

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

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UZ Brussel

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

blood sampling

Procedure

comparison between corifollitropin alfa and follitropin beta in IVM cycles

transvaginal ultrasound scanning

Procedure

comparison between corifollitropin alfa and follitropin beta in IVM cycles

oocyte retrieval for IVM

Procedure

comparison between corifollitropin alfa and follitropin beta in IVM cycles

Corifollitropin alfa

Drug

Single injection of 100 micrograms of corifollitropin alfa

Follitropin beta

Drug

Daily injection (three days) of follitropin beta

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.

Primary outcomes

  1. Number of COC

    Time frame: 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 outcomes

  1. Clinical pregnancy rate

    Time frame: At about 6 - 7 weeks gestation

    Clinical pregnancy rate after the first embryo transfer following the IVM cycle

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: Elonva_IVM

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2017
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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