- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434122
Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium
- UZ Brussel
-
-
-
-
-
Prague, Czech Republic
- ISCARE IVF a.s.
-
-
-
-
-
Madrid, Spain
- IVI-Madrid
-
Valencia, Spain
- IVI-Valencia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 Comparator: 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)
Time Frame: Stimulation Day 1
|
Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.
|
Stimulation Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)
Time Frame: 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.
|
7 days after hCG injection
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE200486 CS24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility, Female
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Newlife Fertility CentreRecruitingInfertility | Infertility,Female | Infertility Unexplained | Infertility of Uterine Origin | Infertility; Female, NonimplantationCanada
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Cairo UniversityCompleted
-
Navy General Hospital, BeijingUnknownFemale Infertility Due to Nonimplantation of OvumChina
-
Sapientiae InstituteTerminated
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
IVI MadridCompletedFemale Infertility Due to Advanced Maternal AgeSpain
Clinical Trials on Degarelix mid-luteal, 2.5 mg
-
Ferring PharmaceuticalsCompletedProstate CancerUnited States, Netherlands, Hungary, Czech Republic, Germany, Mexico, Romania, Russian Federation, Ukraine, Canada, Puerto Rico, United Kingdom
-
Ferring PharmaceuticalsCompletedLower Urinary Tract Symptoms (LUTS)United States, Canada, Belgium, Czech Republic, Italy, Poland
-
Ferring PharmaceuticalsCompletedProstate CancerSpain, Netherlands, Belgium, Italy, France, Germany
-
Nymox CorporationCompletedProstate CancerUnited States
-
Eisai Inc.Completed
-
RemeGen Co., Ltd.RecruitingSystemic Lupus ErythematosusChina
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2United States, Germany, Canada, Sweden, Latvia, Finland, Greece, Romania, Czechia, Puerto Rico
-
Minerva NeurosciencesCompletedMajor Depressive DisorderUnited States, Bulgaria, Finland, Georgia, Moldova, Republic of, Poland, Ukraine
-
Ferring PharmaceuticalsFerring Pharmaceuticals Korea, Ltd.CompletedProstate CancerKorea, Republic of
-
Kyowa Kirin Co., Ltd.Completed