DYG Versus Cetrorelix in Oocyte Donation

October 10, 2022 updated by: Jose Antonio Moreno, Clinica de la Mujer Medicina Reproductiva, Chile

Comparison of Reproductive Outcomes After Progestin-primed Ovarian Stimulation With Dydrogesterone Versus Cetrorelix to Inhibit Spontaneous Ovulation in Oocyte Donation

Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter >18mm.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

202

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

21 years to 30 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Oocyte donors undergoing controlled ovarian stimulation

Description

Inclusion Criteria:

  • Oocyte donors between 21 and 30 years old, with regular menstrual cycles (24-35 d) and a body mass index (BMI) between 18 and 28 kg/m2 without any relevant personal or family history

Exclusion Criteria:

  • AMH less than 3 ng/dL
  • A positive screening for sexually transmitted diseases

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DYG
oocyte donors undergoing controlled ovarian stimulation in a progestin-primed ovarian stimulation protocol with DYG protocol (20mg/day)
progestin primed ovarian stimulation
Cetrorelix
oocyte donors undergoing controlled ovarian stimulation in a GnRH antagonist protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live Birth Rate per transfer
Time Frame: 40 weeks after ET
40 weeks after ET
Clinical pregnancy per transfer
Time Frame: 12 weeks after ET
12 weeks after ET
Miscarriage rate
Time Frame: 12 weeks after ET
12 weeks after ET

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of oocytes retrieved
Time Frame: at time of oocyte retrieval
at time of oocyte retrieval
Number of mature oocytes
Time Frame: 1 day after IVF
1 day after IVF
Number of fertilized oocytes
Time Frame: 1 day after IVF
1 day after IVF
Number of blastocists
Time Frame: 5-6 days after OPU
5-6 days after OPU

Collaborators and Investigators

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

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 (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

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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