A randomized multicentre study comparing the effectiveness, safety and tolerance of daily oral dygesterone against Crinone gel for use in in-vitro fertilization (IVF)
- Conditions
- Treatment for the luteal support in in-vitro fertilization (IVF).MedDRA version: 18.1Level: LLTClassification code 10021572Term: In vitro fertilizationSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2012-002993-29-BE
- Lead Sponsor
- Abbott Laboratories GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- 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 at screening
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 or at 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.Subject is not pregnant either confirmed by negative pregnancy test or by of investigator judgement
9.Clinical 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
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 Investigator's 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Demonstrate non-inferiority of oral dydrogesterone in the two treatment regimens versus micronized progesterone vaginal gel. The primary efficacy parameter is the presence of fetal heart beats at 12 weeks’gestation (10 weeks´ pregnancy) determined by transvaginal ultrasound. To obtain safety and tolerability data by means of documenting treatment emergent AEs.;Secondary Objective: The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer and the incidence of live births and healthy newborns.<br>;Primary end point(s): The primary efficacy parameter is the pregnancy rate ;Timepoint(s) of evaluation of this end point: Defined as the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer and the incidence of live births and healthy newborns.;Timepoint(s) of evaluation of this end point: The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer and the incidence of live births and healthy newborns.