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CompletedNCT05577806Updated Oct 13, 2022

DYG Versus Cetrorelix in Oocyte Donation

An observational study in Infertility, Female and Fertility Disorders, sponsored by Clinica de la Mujer Medicina Reproductiva, Chile. Completed. Open to female participants aged 21 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Clinica de la Mujer Medicina Reproductiva, Chile · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
202
Ages
21 Years to 30 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility, Female
  • Fertility Disorders

Keywords

  • Gonadotrophin-releasing hormone (GnRH) analogues
  • Ovarian stimulation
  • Oocyte donation
  • Progestin-primed ovarian stimulation
  • Dydrogesterone
03

Who can participate

Ages eligible
21 Years to 30 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Oocyte donors undergoing controlled ovarian stimulation

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

Exclusion Criteria:

  • AMH less than 3 ng/dL
  • A positive screening for sexually transmitted diseases
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
202 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugDydrogesterone

    progestin primed ovarian stimulation

05

What researchers measure

Primary outcomes

  1. Live Birth Rate per transfer

    Time frame: 40 weeks after ET

  2. Clinical pregnancy per transfer

    Time frame: 12 weeks after ET

  3. Miscarriage rate

    Time frame: 12 weeks after ET

Secondary outcomes

  1. Number of oocytes retrieved

    Time frame: at time of oocyte retrieval

  2. Number of mature oocytes

    Time frame: 1 day after IVF

  3. Number of fertilized oocytes

    Time frame: 1 day after IVF

  4. Number of blastocists

    Time frame: 5-6 days after OPU

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05577806
Lead sponsor
Clinica de la Mujer Medicina Reproductiva, Chile
Responsible party
Jose Antonio Moreno (MD, PhD, Clinica de la Mujer Medicina Reproductiva, Chile) — Principal investigator
First posted
Oct 13, 2022
Start date
Jan 1, 2017
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Oct 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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