CTRI/2016/01/006490Active, not recruitingPhase 3 4
A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg daily versus Crinone 8% intravaginal progesterone gel 90 mg daily for Luteal Support in In-Vitro Fertilization (LOTUS II)
Abbott Laboratories GmbH8 sites in 1 country1,066 target enrollmentStarted: January 15, 2016Last updated:
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Active, not recruiting
- Sponsor
- Abbott Laboratories GmbH
- Enrollment
- 1,066
- Locations
- 8
- Primary Endpoint
- Pregnancy rate defined as the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound.
Study Overview
Brief Summary
The purpose of this randomized, two-arm and open label study is to demonstrate that the treatment
of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose Crinone
8% intravaginal progesterone gel 90 mg for the luteal support in women who are unable to conceive
a child and are undergoing IVF. The treatment will start on the day of oocyte retrieval and continue
until pregnancy is negative or until week 12 gestation.
Patients will be followed during treatment until 30 days after delivery to record any safety and
tolerability data of the patient and their newborn (s).
Study Design
- Study Type
- Interventional
- Masking
- Open Label
Eligibility Criteria
- Ages
- 19.00 Year(s) to 41.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Signed informed consent;
- •Premenopausal females, age > 18 years < 42 years
- •Non-smokers.
- •For females who were past smokers, they must have stopped tobacco usage for at least 3 months prior baseline visit
- •Early follicular phase (Day 2-4) FSH (Follicle stimulating hormone) less than or equal to 15 IU/L and estradiol (E2)within normal limits
- •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
- •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)
- •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)
- •Negative pregnancy test on the day of pituitary down regulation (prior to administration of GnRH agonist or GnRH antagonist)
- •Clinically indicated protocol for induction of IVF with a fresh embryo
- •Single or dual embryo transfer
- •BMI ≥ 18 and ≤ 30 kg/m2.
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 (< 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.
Outcomes
Primary Outcomes
Pregnancy rate defined as the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound.
Time Frame: Pregnancy rate defined as the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound.
Secondary Outcomes
- Status Newborn (The gender, APGAR score, height, weight and head circumference, physical examination and any malformations of the newborn(s) will be recorded.)(After delivery (about 9 months after IVF))
- Rate of successful completion of pregnancy (Incidence of live births and healthy newborns)(After delivery (about 9 months after IVF))
- Adverse Events (Safety and Tolerability data (mother and child) )(until Study Completion)
- Positive biochemical pregnancy test on Day 14 after embryo transfer(Day 14 after embryo transfer)
Investigators
Study Sites (8)
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