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

October 6, 2020 updated by: Papanikolaou Evaggelos, Assisting Nature

Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • Assisting Nature

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 34 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women 20-34 years old who follow COS with a single GnRH antagonist Degarelix or multidose GnRH antagonist Ganirelix.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate according to stimulation protocol
Time Frame: Up to 38 weeks after embryo transfer
Live birth rate according to stimulation protocol
Up to 38 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastulation rate according to stimulation protocol
Time Frame: Up to 6 days post oocyte retrieval
Blastulation rate according to stimulation protocol
Up to 6 days post oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assisting Nature

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Single-VS-multiple dose- AN007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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