Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
145 participants
INTERVENTIONAL
2017-11-01
2022-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Elonva
A single injection of 100 microgram corifollitropin alfa. Oocyte retrieval on day five after corifollitropin alfa injection.
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
Corifollitropin Alfa
Single injection of 100 micrograms of corifollitropin alfa
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.
Puregon
Three daily injections of 150 IU follitropin beta. Oocyte retrieval on day five after the first follitropin beta injection.
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
36 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Michel De Vos
Medical director
Locations
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UZ Brussel
Brussels, , Belgium
Countries
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Other Identifiers
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2017.corifollitropinalfa_IVM
Identifier Type: -
Identifier Source: org_study_id
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