Oral dydrogesterone (OD) versus micronized vaginal progesterone (MVP) for luteal phase support (LPS) in IVF/ICSI: pharmacokinetics and the impact on the endometrium, the microbiota of the genital tract and the peripheral immunology. Double blind crossover study. - OD versus MVP for LPS in IVF/ICSI

Z Brussel0 个研究点目标入组 30 人开始时间: 2018年11月23日最近更新: 2024年3月12日

试验速览

暂无简介。

•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

•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

发起方

Z Brussel