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Optimisation of Follicular Recruitment in IVM Cycles

NCT03197077 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-04-07

No results posted yet for this study

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 ?

Conditions

  • Infertility, Female
  • Polycystic Ovary Syndrome

Interventions

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03197077 on ClinicalTrials.gov