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Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

Primary Purpose

Infertility, Female

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Degarelix mid-luteal, 2.5 mg

Placebo

About this trial

This is an interventional prevention trial for Infertility, Female focused on measuring Assisted Reproductive Technology (ART), oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria

Signed Informed Consent Form, prior to screening evaluations
In good physical and mental health
Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation
Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory
Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
Willing to donate the retrieved oocytes
Willing to use an adequate barrier method of contraception from informed consent to Day hCG injection +7 and to use an adequate barrier or hormonal method of contraception from Day hCG injection +7 to the end-of-study visit

Exclusion Criteria

Abnormal karyotype
Any known clinically significant systemic disease (e.g., insulin dependent diabetes)
Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
Diagnosed with polycystic ovarian syndrome or endometriosis stage III/IV
Diagnosed as "poor responder"
History of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy)
Pregnancy or lactation
Use of any investigational drug during 3 months prior to start of the current COH cycle
Previous participation in the study
Hypersensitivity to any trial product

Sites / Locations

UZ Brussel
ISCARE IVF a.s.
IVI-Madrid
IVI-Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Degarelix mid-luteal, 2.5 mg

Placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)

Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.

Secondary Outcome Measures

Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)

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.

Full Information

NCT ID

NCT00434122

First Posted

February 9, 2007

Last Updated

May 18, 2011

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00434122

Brief Title

Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

Official Title

A Randomised, Assessor-blind, Parallel Groups, Multi-centre, Exploratory Study Assessing the Impact of Subcutaneous Administration of Degarelix 2.5 mg on Synchronisation of Follicle Cohort Compared to Placebo and Evaluating the Effects of Degarelix 2.5 mg Started in the Mid-luteal or Early Follicular Phase on Endometrial Receptivity Compared to a Fixed Gonadotrophin Releasing Hormone Antagonist Protocol in Oocyte Donors Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Technologies

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Female

Keywords

Assisted Reproductive Technology (ART), oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Degarelix mid-luteal, 2.5 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Degarelix mid-luteal, 2.5 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)

Description

Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.

Time Frame

Stimulation Day 1

Secondary Outcome Measure Information:

Title

Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)

Description

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.

Time Frame

7 days after hCG injection

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Signed Informed Consent Form, prior to screening evaluations In good physical and mental health Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive) Willing to donate the retrieved oocytes Willing to use an adequate barrier method of contraception from informed consent to Day hCG injection +7 and to use an adequate barrier or hormonal method of contraception from Day hCG injection +7 to the end-of-study visit Exclusion Criteria Abnormal karyotype Any known clinically significant systemic disease (e.g., insulin dependent diabetes) Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study Diagnosed with polycystic ovarian syndrome or endometriosis stage III/IV Diagnosed as "poor responder" History of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy) Pregnancy or lactation Use of any investigational drug during 3 months prior to start of the current COH cycle Previous participation in the study Hypersensitivity to any trial product

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development Support

Organizational Affiliation

Ferring Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

UZ Brussel

City

Brussels

Country

Belgium

Facility Name

ISCARE IVF a.s.

City

Prague

Country

Czech Republic

Facility Name

IVI-Madrid

City

Madrid

Country

Spain

Facility Name

IVI-Valencia

City

Valencia

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

22197127

Citation

Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4.

Results Reference

derived

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Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

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