Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434122
• Other study ID #: FE200486 CS24
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2007
• Last updated: May 18, 2011
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infertility, Female

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels
Czech Republic	ISCARE IVF a.s.	Prague
Spain	IVI-Madrid	Madrid
Spain	IVI-Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes