CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
Elonvadrug
Likely dose
Elonva 150 mcgfrom 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/NCT02606500
NCT02606500Phase 4Completed
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Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success

University Medical Centre Ljubljana·interventional·Posted Nov 17, 2015·Updated Nov 26, 2018

In Brief

A Phase 4 clinical trial evaluating Elonva for Obesity. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women. Furthermore, investigators want to determine whether oocytes retrieved from normal weighing and obese women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular level.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesSlovenia
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 17, 2015
Enrollment StartMar 1, 2016
Primary CompletionJan 1, 2017
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.6 years ago

Interventions

Elonvadrug

20 obese women will be the study group and 20 normal weighing women will be the control group. Both groups will receive 150 mcg of Elonva for controlled ovarian hyperstimulation (COH). Gonadotropin-releasing hormone (GnRH) antagonist will be used to prevent premature luteinizing hormone (LH) surge. Additional daily doses of 200 IU of recombinant follicle stimulating hormone (rFSH) will be used if necessary. Human chorionic gonadotropin (hCG) will be used for oocyte maturation. 2 mature follicles will be aspirated separately in each patient. Cumulus cell (CC) samples will be collected and stored on -80 oC for subsequent analysis. Clinical and molecular parameters of IVF success will be assessed and compared between the groups. The exclusion criteria will be: polycystic ovary syndrome, severely abnormal sperm parameters, and age \> 38 years.