Clinical trial NCT00434122: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility, Female
Keywords: Assisted Reproductive Technology (ART)
oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)
timeFrame: Stimulation Day 1
Secondary outcomes:
measure: Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG)
timeFrame: 7 days after hCG injection
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
city: Prague
country: Czech Republic
facility: ISCARE IVF a.s.
city: Madrid
country: Spain
facility: IVI-Madrid
city: Valencia
country: Spain
facility: IVI-Valencia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
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.