Optimisation of Follicular Recruitment in IVM Cycles

Polycystic Ovary Syndrome Clinical Trial

— Elonva_IVM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197077
• Other study ID #: 2017.corifollitropinalfa_IVM
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Polycystic Ovary Syndrome

Intervention

Procedure:
• blood sampling
comparison between corifollitropin alfa and follitropin beta in IVM cycles
• transvaginal ultrasound scanning
comparison between corifollitropin alfa and follitropin beta in IVM cycles
• 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
• Follitropin beta
Daily injection (three days) of follitropin beta
• 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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical pregnancy rate	Clinical pregnancy rate after the first embryo transfer following the IVM cycle	At about 6 - 7 weeks gestation