A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone versus Crinone intravaginal progesterone gel for Luteal Support in In-Vitro Fertilization (LOTUS II)
- Conditions
- Health Condition 1: null- Female infertility
- Registration Number
- CTRI/2016/01/006490
- Lead Sponsor
- Abbott Laboratories GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 1066
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
11. BMI >= 18 and <= 30 kg/m2
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.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)