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Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.

Sponsor
Assisting Nature (Other)
Overall Status
Recruiting
CT.gov ID
NCT03861715
Collaborator
(none)
180
Enrollment
1
Location
59
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: live birth rate

Detailed Description

A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.

Study Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Single Dose antagonist Degarelix

The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with a single dose Degarelix.

Diagnostic Test: live birth rate
The blastulation rate and live birth rate according to the protocol of COS
Other Names:
  • blastulation rate

    		•
    Multidose antagonist Ganirelix

    The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with multidose dose Ganirelix.

    Diagnostic Test: live birth rate
    The blastulation rate and live birth rate according to the protocol of COS
    Other Names:
  • blastulation rate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Live birth rate according to stimulation protocol [Up to 38 weeks after embryo transfer]

      Live birth rate according to stimulation protocol

    Secondary Outcome Measures

    1. Blastulation rate according to stimulation protocol [Up to 6 days post oocyte retrieval]

      Blastulation rate according to stimulation protocol

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 34 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age 20-34 years;

    • body mass index (BMI) 18-29kg/m2;

    • regular menstrual cycle of 26-35 days,

    • AMH levels age appropriate (≥2.3 ng/ml)

    • early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).

    Exclusion Criteria:

    • women with diabetes and other metabolic disease

    • women with hereditary genetic diseases;

    • women with heart disease, QT prolongation,heart failure

    • elevated liver enzymes, liver failure, hepatitis

    • women with inflammatory or autoimmune disease

    • abnormal karyotype;

    • endometriosis stage III/IV;

    • history of recurrent miscarriage;

    • severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assisting Nature Thessaloniki Greece 57001

    Sponsors and Collaborators

    • Assisting Nature

    Investigators

    • Principal Investigator: Evaggelos Papanikolaou, MD, PhD, Assisting Nature
    • Principal Investigator: Robert Najdecki, MD, PhD, Assisting Nature

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Papanikolaou Evaggelos, Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic, Assisting Nature
    ClinicalTrials.gov Identifier:
    NCT03861715
    Other Study ID Numbers:
    • Single-VS-multiple dose- AN007
    First Posted:
    Mar 4, 2019
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Papanikolaou Evaggelos, Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic, Assisting Nature
    antagonist protocol
    degarelix antagonist protocol
    degarelix
    IVF
    Additional relevant MeSH terms:
    Infertility
    Primary Ovarian Insufficiency
    Menopause, Premature

    Study Results

    No Results Posted as of Oct 8, 2020