Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

Phase 2

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Degarelix mid-luteal, 2.5 mg; Drug: Placebo

• Registration Number: NCT00434122
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.

Detailed Description

For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase.

After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.

Study Timeline

• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Study Start: 2007-03
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2009-01-19
• Results First Submitted QC: 2009-03-09
• Results First Posted: 2009-04-10
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix mid-luteal, 2.5 mg	Degarelix mid-luteal, 2.5 mg	Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
Placebo	Placebo	Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.

Primary Outcome Measures

Name	Time	Method
Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)	Stimulation Day 1	Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.

Secondary Outcome Measures

Name	Time	Method
Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)	7 days after hCG injection	An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day.

Trial Locations

Locations (4)

IVI-Madrid; 🇪🇸 Madrid, Spain

ISCARE IVF a.s.; 🇨🇿 Prague, Czech Republic

IVI-Valencia; 🇪🇸 Valencia, Spain

UZ Brussel; 🇧🇪 Brussels, Belgium