CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 234 enrolled
Drug / intervention
Ganirelix 0.25 mg. +2 moredrug
Likely dose
Ganirelix 0.25 mg.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02118051
NCT02118051Phase 3Completed
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Prospective Randomized Study for the Evaluation of Controlled Ovarian Stimulation With Corifollitropin Alpha in Patients With Expected or Poor Ovarian Response in IVF Cycles

Instituto de Investigacion Sanitaria La Fe·interventional·Posted Apr 21, 2014·Updated Jun 12, 2017

In Brief

A Phase 3 clinical trial evaluating Ganirelix 0.25 mg., Recombinant choriogonadotropin alfa, and 1 other intervention for Infertility. Completed, enrolled 234 participants across 1 site.

Detailed Summary

Patients who have had or are expected to have a poor ovarian response (POR), because they meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro fertilization (IVF). In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH) antagonists

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 21, 2014
Enrollment StartSep 1, 2013
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.2 years ago

Interventions

Ganirelix 0.25 mg.drug

Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle\> 14mm.

Recombinant choriogonadotropin alfadrug

Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles\> 17 mm are observed

Micronized natural progesterone.drug

Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.