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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

NCTNCT00434122 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS24
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
85 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Single masking
Countries
3 countries

Belgium, Czechia, Spain

Start
Mar 2007
Primary completion
Dec 2007
Completion
Dec 2007
First posted
12 Feb 2007 (estimated)
Last update posted
2 Jun 2011 (estimated)
Conditions
Infertility, Female

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008
  1. Ph 2

    Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix

    NCT00434122

    Mar 2007 to Dec 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Degarelix mid-luteal, 2.5 mgDrug
  • PlaceboDrug

Arms2

  • Experimental

    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 comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)

    Time frame · Stimulation Day 1

    Registry description

    Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution.

Secondary outcomes(1)

  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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Stimulation Day 1

Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm)

GroupValue (Percentage)Spread
Degarelix Mid-luteal, 2.5 mg36.75.6
Placebo39.29.5
Secondary and other outcome results(1)
Secondary outcomeNumber· 7 days after hCG injection

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

GroupValue (Participants)
Degarelix Mid-luteal, 2.5 mg31
Degarelix Follicular, 2.5 mg11
Ganirelix, 0.25 mg14

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix, 2.5 mgCombination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg. 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. Degarelix Follicular, 2.5 mg: 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.–1 / 637 / 63
Ganirelix, 0.25 mgPlacebo 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.–0 / 224 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

4 results

Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial.

García-Velasco et al. 2012Reproductive biomedicine onlinecited by 3

PMID 22197127DOI 10.1016/j.rbmo.2011.10.016PUB-22197127

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 35 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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