NCT05577806

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

5 years

First QC Date

October 10, 2022

Last Update Submit

October 10, 2022

Conditions

Infertility, FemaleFertility Disorders

Keywords

Gonadotrophin-releasing hormone (GnRH) analoguesOvarian stimulationOocyte donationProgestin-primed ovarian stimulationDydrogesterone

Outcome Measures

Primary Outcomes (3)

  • Live Birth Rate per transfer

    40 weeks after ET

  • Clinical pregnancy per transfer

    12 weeks after ET

  • Miscarriage rate

    12 weeks after ET

Secondary Outcomes (4)

  • Number of oocytes retrieved

    at time of oocyte retrieval

  • Number of mature oocytes

    1 day after IVF

  • Number of fertilized oocytes

    1 day after IVF

  • Number of blastocists

    5-6 days after OPU

Study Arms (2)

DYG

oocyte donors undergoing controlled ovarian stimulation in a progestin-primed ovarian stimulation protocol with DYG protocol (20mg/day)

Drug: Dydrogesterone

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

Interventions

DydrogesteroneDRUG

progestin primed ovarian stimulation

DYG

Eligibility Criteria

Age21 Years - 30 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Oocyte donors undergoing controlled ovarian stimulation

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Interventions

Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

January 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 13, 2022

Record last verified: 2022-10