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

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

• Infertility, Female
• Infertility
• Genital Diseases, Male
• Genital Diseases, Female
• Progesterone
• Dydrogesterone
• Hormones
• Hormones, Hormone Substitutes, and Hormone Antagonists
• Physiological Effects of Drugs
• Progestins

Interventions

DRUG

Dydrogesterone Oral Tablet

Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days

DRUG

Micronized progesterone

Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days

DRUG

Placebo Dydrogesterone oral tablet

Tablet, indistinguishable from dydrogesterone oral tablet

DRUG

Placebo Micronized progesterone

Capsule, indistinguishable from micronized vaginal progesterone capsules

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf

  collaborator OTHER

• Abbott

  collaborator INDUSTRY

• KU Leuven

  collaborator OTHER

• CRG UZ Brussel

  lead OTHER

Principal Investigators

• Herman Tournaye, PhD, MD · Head of department CRG

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-01

Primary Completion

2020-08-24

Completion

2020-08-24

Countries

• Belgium

Study Locations