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)

This study is ongoing, but not recruiting participants.
Quintiles, Inc.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 19, 2013
Last updated: July 1, 2015
Last verified: July 2015
Female inability to conceive a child. The purpose of this randomized, two-arm and double-blind 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 during treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

Condition Intervention Phase
Female Infertility
Drug: Dydrogesterone 30 mg
Drug: Micronized Progesterone 600 mg
Drug: Placebo progesterone
Drug: Placebo dydrogesterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pregnancy Rate [ Time Frame: 12 weeks´ gestation ] [ Designated as safety issue: No ]
    Pregnancy rate defined as the presence of fetal heart beats at 12 weeks´gestation determined by transvaginal ultrasound

Secondary Outcome Measures:
  • Positive Pregnancy test rate [ Time Frame: Day 14 after embryo transfer ] [ Designated as safety issue: No ]
    Positive biochemical pregnancy test on Day 14 after embryo transfer

  • Rate of successful completion of pregnancy [ Time Frame: After delivery (about 9 months after IVF) ] [ Designated as safety issue: No ]
    Incidence of live births and healthy newborns

  • Adverse Events [ Time Frame: Study Completion (about 10 months after IVF) ] [ Designated as safety issue: Yes ]
    Safety data

  • Status newborn [ Time Frame: After delivery (about 9 months after IVF) ] [ Designated as safety issue: Yes ]
    The gender, APGAR score, height, weight and head circumference, physical examination and any malformations of the newborn(s) will be recorded

  • Adverse Events [ Time Frame: At Study Completion (about 10 months after IVF) ] [ Designated as safety issue: Yes ]
    Tolerability Data

Estimated Enrollment: 1066
Study Start Date: July 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   19 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01850030

  Show 40 Study Locations
Sponsors and Collaborators
Quintiles, Inc.
Study Director: Darline Cheatham-Seitz, MD, PhD Abbott
  More Information

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01850030     History of Changes
Other Study ID Numbers: M13-563  2012-002215-26 
Study First Received: April 19, 2013
Last Updated: July 1, 2015
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee
Israel: Ministry of Health
Israel: Ethics Commission
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ministry of Health
Spain: Ethics Committee
Finland: Finnish Medicines Agency
Finland: Ethics Committee

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016