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Completed

NCT Number: NCT00434122

Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UZ Brussel, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Degarelix mid-luteal, 2.5 mg

Drug

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

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 12, 2007
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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