A study to compare if 30mg of oral Dydrogesterone is as good, tolerable and safe as 600mg of intravaginal capsules for luteal support in IVF pregnancies. This study will be conducted at several study sites and neither the patient or the doctor will know which of the two different treatments a patient will receive.

Phase 1

Conditions: Female infertility
MedDRA version: 14.1Level: LLTClassification code 10003540Term: Assisted fertilizationSystem Organ Class: 100000004865
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2012-002215-26-ES

Lead Sponsor: Abbott Laboratories GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1066

Inclusion Criteria

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
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 1066
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. 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
11. Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests
12. History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages