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Oral Dydrogesterone vs Vaginal Progesterone for Luteal Phase Support in Oocyte Donors
NCT03677336Phase 4
Key facts
- Status
- Completed
- Start
- May 2019
- Primary completion
- Aug 2020
- Countries
- 1
- Sponsor
- CRG UZ Brussel
- Modality
- Orthosteric Ligands
- Drugs
- dydrogesterone
- Conditions
- infertility
01
Overview
Phase 4, randomised, double-blind trial of dydrogesterone in infertility (2 arms), sponsored by CRG UZ Brussel. Primary endpoints: Molecular endometrial level using illumina RNA-seq, Molecular endometrial level using immunohistochemistry and 1 more. Started May 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dydrogesterone -> Progesterone
Cycle 1: Oral Dydrogesterone + Placebo Vaginal. Cycle 2: Vaginal Progesterone + Placebo Oral.
Progesterone -> Dydrogesterone
Cycle 1: Vaginal Progesterone + Placebo Oral. Cycle 2: Oral Dydrogesterone + Placebo Vaginal.
03
Who it enrols
Healthy oocyte donor candidates with regular cycles, BMI 18-29, and normal AMH levels.
04
Endpoints
Primary
Molecular endometrial level using illumina RNA-seq
Molecular endometrial level using immunohistochemistry
Molecular endometrial level using flow cytometry
Secondary
Difference in pharmacokinetic profile: Progesterone: AUC0-tau
Difference in pharmacokinetic profile: Progesterone: Cmax
Difference in pharmacokinetic profile: Dydrogesterone and 20alpha-dihydrodydrogesterone: AUC0-tau
Difference in peripheral immunology
Difference in microbiota in the female genital tract
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