Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

NCT00434122 | Completed Phase 2 Results

• 1 other identifier: FE200486 CS24
• Study Type: interventional
• Target: 85
• Locations: 3 countries
• Sites: 4

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.

Conditions

Infertility, Female

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  7 days after hCG injection

Study Arms (2)

Degarelix mid-luteal, 2.5 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Degarelix mid-luteal, 2.5 mg

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (4)

UZ Brussel

Brussels, Belgium

Location

ISCARE IVF a.s.

Prague, Czechia

Location

IVI-Madrid

Madrid, Spain

Location

IVI-Valencia

Valencia, Spain

Location

Related Publications (1)

• 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.

  PMID: 22197127 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Results Point of Contact

• Title: Ferring Pharmaceuticals
• Organization: Clinical Development Support

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2007
• First Posted: February 12, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 2, 2011
• Results First Posted: April 10, 2009

Record last verified: 2011-05

Locations

BE (1); CZ (1); ES (2)