Support of the implantation of the embryo after transferring to the uterus in IVF/ICSI: a comparison between taking progesterone by mouth or vaginal.

Phase 1

• Conditions: Female infertility; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2018-000105-23-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-23
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1.Age >18 years and <35 years
2.Oocyte donor candidates
3.Regularly cycling
4.BMI =18 and = 29 kg/m2
5.Signed informed consent
6.Non-smokers.
7.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)
8.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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Intra-uterine device
2.Previous enrollment
3.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
4.Acute urogenital disease during the course of the study
5.Known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients)
6.Intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start.
7.Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study.
8.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)
9.Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests.
10.Known or suspected progestogen dependent neoplasms (e.g. meningioma)
11.Serum progesterone level >1.5 ng/mL at ovulation triggering

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified