Health Condition 1: null- Female infertility
Conditions
Interventions
Intervention1: Dydrogesterone tablets: Dose: 10 mg
Frequency: Three times a day
Duration: Until pregnancy is negative or until week 12 gestation
Route of administration: Oral
Control Intervention1: Cr
Sponsors
Abbott Laboratories GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed informed consent; 2. Premenopausal females, age > 18 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 11. BMI >= 18 and <= 30 kg/m2
Exclusion criteria
Exclusion criteria: 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 ( 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.Intake of experimental drug or any participation in any other clinical trial within 30 days prior to study start 5.Mental disability or any other lack of fitness, in the investigators opinion, to preclude subjects in or to complete the study 6.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) 7.History of chemotherapy 8.Patients with more than 3 unsuccessful IVF attempts 9.Contraindication for pregnancy 10.Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests 11.History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate defined as the presence of fetal heart beats at 12 weeksâ?? gestation determined by transvaginal ultrasound.Timepoint: Pregnancy rate defined as the presence of fetal heart beats at 12 weeksâ?? gestation determined by transvaginal ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (Safety and Tolerability data (mother and child) )Timepoint: until Study Completion;Positive biochemical pregnancy test on Day 14 after embryo transferTimepoint: Day 14 after embryo transfer;Rate of successful completion of pregnancy (Incidence of live births and healthy newborns)Timepoint: After delivery (about 9 months after IVF);Status Newborn (The gender, APGAR score, height, weight and head circumference, physical examination and any malformations of the newborn(s) will be recorded.)Timepoint: After delivery (about 9 months after IVF) | — |
Countries
Australia, Belgium, China, Germany, Hong Kong, India, Russian Federation, Singapore, Thailand, Ukraine
Contacts
Public ContactDrBalagopal Nair
Abbott India Limited
Outcome results
None listed