Trial record 1 of 1 for:
NCT01850030
A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization (Lotus I)
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| ClinicalTrials.gov Identifier: NCT01850030 |
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Recruitment Status :
Completed
First Posted : May 9, 2013
Results First Posted : January 2, 2018
Last Update Posted : January 2, 2018
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Sponsor:
Abbott
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
Abbott
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Brief Summary:
Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients 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 after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Female Infertility | Drug: Dydrogesterone 30 mg Drug: Micronized Progesterone 600 mg Drug: Placebo progesterone Drug: Placebo dydrogesterone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1070 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-Blind, Double-Dummy, Randomized, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization (Lotus I) |
| Study Start Date : | August 2013 |
| Actual Primary Completion Date : | March 2016 |
| Actual Study Completion Date : | March 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Infertility
Drug Information available for:
Progesterone
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dydrogesterone 30 mg |
Drug: Dydrogesterone 30 mg
Oral Dydrogesterone 10 mg tablets tid Drug: Placebo progesterone Placebo intravaginal micronized progesterone 200 mg capsules tid |
| Experimental: Micronized Progesterone 600 mg |
Drug: Micronized Progesterone 600 mg
Intravaginal micronized progesterone 200 mg capsules tid Drug: Placebo dydrogesterone placebo oral dydrogesterone 10 mg tablets tid |
Primary Outcome Measures :
- Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound [ Time Frame: 12 weeks´ gestation (at visit 6) ]Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound
Secondary Outcome Measures :
- Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer [ Time Frame: Day 14 after embryo transfer ]Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer
- Percentage of Participants With a Successful Completion of Pregnancy [ Time Frame: After delivery (about 9 months after IVF) ]Incidence of live births and healthy newborns
- Gender of the Newborn [ Time Frame: After delivery (about 9 months after IVF) ]was recorded and collected for Newborn
Information from the National Library of Medicine
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| Ages Eligible for Study: | 19 Years to 41 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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) Follicle stimulating hormone (FSH) less than or equal to 15 IU/L and estradiol (E2)within normal limits
- Luteinizing hormone (LH), prolactin (PRL), T (testosterone) and thyroid-stimulating hormone (TSH), 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 Assisted Reproductive Technology (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 gonadotropin releasing hormones (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:
- Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose, throat (HEENT), 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
- Acute urogenital disease
- Known allergic reactions to progesterone products
- Known allergic reactions to peanuts and peanut oil
- Intake of experimental drug or participation in any other clinical trial within 30 days prior to study start
- Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects to participate in or to complete the study
- 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)
- History of chemotherapy or radiotherapy
- Patients with more than 3 unsuccessful IVF attempts
- Contraindication for pregnancy
- Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850030
Locations
Show 40 study locations
Sponsors and Collaborators
Abbott
Quintiles, Inc.
Investigators
| Study Director: | Darline Cheatham-Seitz, MD, PhD | Abbott |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01850030 |
| Other Study ID Numbers: |
M13-563 2012-002215-26 ( EudraCT Number ) |
| First Posted: | May 9, 2013 Key Record Dates |
| Results First Posted: | January 2, 2018 |
| Last Update Posted: | January 2, 2018 |
| Last Verified: | May 2017 |
Additional relevant MeSH terms:
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Infertility Infertility, Female Progesterone Dydrogesterone |
Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |