DYG Versus Cetrorelix in Oocyte Donation

Sponsor

Clinica de la Mujer Medicina Reproductiva, Chile (Other)

Overall Status

Completed

CT.gov ID

NCT05577806

Collaborator

(none)

202

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Fertility Disorders	Drug: Dydrogesterone

Study Design

Study Type:

Observational

Anticipated Enrollment :

202 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
DYG oocyte donors undergoing controlled ovarian stimulation in a progestin-primed ovarian stimulation protocol with DYG protocol (20mg/day)	Drug: Dydrogesterone 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

Arm

Intervention/Treatment

DYG

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

Drug: Dydrogesterone

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

Outcome Measures

Primary Outcome Measures

Live Birth Rate per transfer [40 weeks after ET]
Clinical pregnancy per transfer [12 weeks after ET]
Miscarriage rate [12 weeks after ET]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 30 Years

Sexes Eligible for Study:

Female

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