A Double-Blind, Double-Dummy, Randomized, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg daily versus Intravaginal Micronized Progesterone Capsules 600 mg daily for Luteal Support in In-Vitro Fertilization - Lotus I

Abbott Laboratories GmbH0 sites1,066 target enrollmentDecember 19, 2013

Overview

No summary available.

Registry

who.int

Start Date

December 19, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•1\. Signed informed consent;
•2\. Premenopausal females, age \> 18 years \< 42 years
•3\. Non\-smokers. For females who were past smokers, they must have stopped tobacco usage for at least 3 months prior baseline visit
•4\. Early follicular phase (Day 2\-4\) FSH (Follicle stimulating hormone) less than or equal to 15 IU/L and estradiol (E2\)within normal limits
•5\. LH (luteinizing hormone), PRL (prolactin), T (testosterone) and TSH (thyroid\-stimulating hormone), within the normal limits for the clinical laboratory, or considered not clinically significant by the Investigator within 6 months prior to screening
•6\. Documented history of infertility (e.g., unable to conceive for at least one year or for 6 months for women \= 38 years of age or bilateral tubal occlusion or absence)
•7\. Normal transvaginal ultrasound at screening (or within 14 days of screening) without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids)
•8\. Negative pregnancy test on the day of pituitary down regulation (prior to administration of GnRH agonist or GnRH antagonist)
•9\. Clinically indicated protocol for induction of IVF with a fresh embryo
•10\. Single or dual embryo transfer

•1\. 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;
•2\. Acute urogenital disease
•3\. Known allergic reactions to progesterone products
•4\. Known allergic reactions to peanuts and peanut oil
•5\. Intake of experimental drug or participation in any other clinical trial within 30 days prior to study start
•6\. Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects to participate in or to complete the study
•7\. Current or recent substance abuse, including alcohol and tobacco (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
•8\. History of chemotherapy or radiotherapy
•9\. Patients with more than 3 unsuccessful IVF attempts
•10\. Contraindication for pregnancy