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Optimisation of Follicular Recruitment in IVM Cycles (Elonva_IVM)

Primary Purpose

Infertility, Female, Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
blood sampling
transvaginal ultrasound scanning
oocyte retrieval for IVM
Corifollitropin Alfa
Follitropin beta
oral contraceptive pill pretreatment (Marvelon)
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UZ Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elonva

Puregon

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of COC
Number of oocyte cumulus complexes obtained on the day of oocyte retrieval.

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2017
Last Updated
April 6, 2023
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03197077
Brief Title
Optimisation of Follicular Recruitment in IVM Cycles
Acronym
Elonva_IVM
Official Title
A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elonva
Arm Type
Experimental
Arm Description
A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
Arm Title
Puregon
Arm Type
Active Comparator
Arm Description
Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
Intervention Type
Procedure
Intervention Name(s)
blood sampling
Intervention Description
comparison between corifollitropin alfa and follitropin beta in IVM cycles
Intervention Type
Procedure
Intervention Name(s)
transvaginal ultrasound scanning
Intervention Description
comparison between corifollitropin alfa and follitropin beta in IVM cycles
Intervention Type
Procedure
Intervention Name(s)
oocyte retrieval for IVM
Intervention Description
comparison between corifollitropin alfa and follitropin beta in IVM cycles
Intervention Type
Drug
Intervention Name(s)
Corifollitropin Alfa
Intervention Description
Single injection of 100 micrograms of corifollitropin alfa
Intervention Type
Drug
Intervention Name(s)
Follitropin beta
Intervention Description
Daily injection (three days) of follitropin beta
Intervention Type
Drug
Intervention Name(s)
oral contraceptive pill pretreatment (Marvelon)
Intervention Description
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 Outcome Measure Information:
Title
Number of COC
Description
Number of oocyte cumulus complexes obtained on the day of oocyte retrieval.
Time Frame
5 days after the first gonadotropin injection (on the day of oocyte retrieval)
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Clinical pregnancy rate after the first embryo transfer following the IVM cycle
Time Frame
At about 6 - 7 weeks gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Optimisation of Follicular Recruitment in IVM Cycles

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