Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: Degarelix mid-luteal, 2.5 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix mid-luteal, 2.5 mg<br>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. | Drug: Degarelix mid-luteal, 2.5 mg<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assisted Reproductive Technology (ART), oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies