Clinical Trials Directory

Trials / Completed

CompletedNCT03677336

Oral Dydrogesterone (OD) Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in IVF/ICSI

Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in In Vitro Fertilisation (IVF)/ IntraCytoplasmic Sperm Injection (ICSI): Pharmacokinetics and the Impact on the Endometrium, the Microbiota of the Genital Tract and the Peripheral Immunology. Double Blind Crossover Study.

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
30 (actual)
Sponsor
CRG UZ Brussel · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.

Conditions

Interventions

TypeNameDescription
DRUGDydrogesterone Oral TabletTablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
DRUGMicronized progesteroneCapsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
DRUGPlacebo Dydrogesterone oral tabletTablet, indistinguishable from dydrogesterone oral tablet
DRUGPlacebo Micronized progesteroneCapsule, indistinguishable from micronized vaginal progesterone capsules

Timeline

Start date
2019-05-01
Primary completion
2020-08-24
Completion
2020-08-24
First posted
2018-09-19
Last updated
2020-12-17

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03677336. Inclusion in this directory is not an endorsement.