- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05577806
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
Conditions
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPOS-DU-OD
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.
Clinical Trials on Infertility, Female
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Newlife Fertility CentreRecruitingInfertility | Infertility,Female | Infertility Unexplained | Infertility of Uterine Origin | Infertility; Female, NonimplantationCanada
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Cairo UniversityCompleted
-
Navy General Hospital, BeijingUnknownFemale Infertility Due to Nonimplantation of OvumChina
-
Sapientiae InstituteTerminated
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
IVI MadridCompletedFemale Infertility Due to Advanced Maternal AgeSpain
Clinical Trials on Dydrogesterone
-
AbbottQuintiles, Inc.CompletedFemale InfertilityAustria, Belgium, Finland, Germany, Israel, Russian Federation, Spain
-
Trieu, Nguyen Thi, M.D.Completed
-
AbbottCompletedEndometriosisRussian Federation
-
Laniado HospitalNot yet recruitingInfertility | IVFIsrael
-
Chulalongkorn UniversityCompleted
-
CRG UZ BrusselKU Leuven; Abbott; Universitätsklinikum Hamburg-EppendorfCompletedInfertility | Infertility, Female | Dydrogesterone | Genital Diseases, Female | Progesterone | Hormones | Physiological Effects of Drugs | Genital Diseases, Male | Hormones, Hormone Substitutes, and Hormone Antagonists | ProgestinsBelgium
-
Fudan UniversityRecruitingIdiopathic Hypogonadotropic Hypogonadism | Luteal Phase Support | Luteal Phase DeficiencyChina
-
Wolfson Medical CenterUnknown
-
National University of MalaysiaCompletedIVF | Clinical Pregnancy Rate | Ovarian Hyperstimulation | Oocyte Maturation Defect 1Malaysia