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

CRG UZ Brussel

Status and phase: Completed; Phase 4

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

Treatments: Drug: Placebo Dydrogesterone oral tablet; Drug: Placebo Micronized progesterone; Drug: Dydrogesterone Oral Tablet; Drug: Micronized progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03677336

DYDRA001

2018-000105-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Oocyte donor candidates
• Regularly cycling
• BMI ≥18 and ≤ 29 kg/m2
• Signed informed consent
• Non-smokers.
• AMH <7,53 and >1,18 ng/mL (90th and 10th percentile for healthy women aged 25-29 according to the used Elecsys® AMH kit by Roche)
• PRL, T and TSH within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior or at screening

Exclusion criteria

• Intra-uterine device
• Previous enrollment
• Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study
• Acute urogenital disease during the course of the study
• Known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients)
• Intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start.
• Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study.
• Current or recent substance abuse, including alcohol and tobacco (patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
• Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests.
• Known or suspected progestogen dependent neoplasms (e.g. meningioma)
• Serum progesterone level >1.5 ng/mL at ovulation triggering

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Group l: 1st cycle MVP/placebo OD

Other group

Description:

2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle. * 1st cycle: Start on day of oocyte retrieval (OR) (=d1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized vaginal progesterone 200 mg capsules 3 times daily, for 8 days. * 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): 'Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo 'Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days.

Treatment:

Drug: Micronized progesterone

Drug: Dydrogesterone Oral Tablet

Drug: Placebo Micronized progesterone

Drug: Placebo Dydrogesterone oral tablet

Group ll: 1st cycle placebo MVP/OD

Other group

Description:

2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle. * 1st cycle: Start on day of oocyte retrieval (OR) (=day 1): Micronized Progesterone 200 mg intravaginal capsules 3 times daily + placebo Dydrogesterone Oral Tablet 10 mg 3 times daily, for 8 days. * 2nd cycle: Start on day of oocyte retrieval (OR) (=day 1): Dydrogesterone Oral Tablet 10 mg 3 times daily + Placebo micronized progesterone 200 mg intravaginal capsules 3 times daily, for 8 days.

Treatment:

Drug: Micronized progesterone

Drug: Dydrogesterone Oral Tablet

Drug: Placebo Micronized progesterone

Drug: Placebo Dydrogesterone oral tablet