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Optimisation of Follicular Recruitment in IVM Cycles (Elonva_IVM)

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ClinicalTrials.gov Identifier: NCT03197077
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Michel De Vos, Universitair Ziekenhuis Brussel

Brief 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 ?

Condition or disease Intervention/treatment Phase
Infertility, Female Polycystic Ovary Syndrome Procedure: blood sampling Procedure: transvaginal ultrasound scanning Procedure: oocyte retrieval for IVM Drug: Corifollitropin Alfa Drug: Follitropin beta Drug: oral contraceptive pill pretreatment (Marvelon) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


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: Follitropin beta
Daily injection (three days) of follitropin beta

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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: At about 6 - 7 weeks gestation ]
    Clinical pregnancy rate after the first embryo transfer following the IVM cycle



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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197077


Contacts
Contact: Elsie Nulens +3224776648 elsie.nulens@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Brussels, Belgium, 1090
Contact: Elsie Nulens    +3224776648    elsie.nulens@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Merck Sharp & Dohme Corp.

Responsible Party: Michel De Vos, Medical director, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03197077     History of Changes
Other Study ID Numbers: 2017.corifollitropinalfa_IVM
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Infertility, Female
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Contraceptive Agents
Desogestrel
Contraceptives, Oral
Follicle Stimulating Hormone
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic
Progestins