A Study to Compare if 30mg/Day of Oral Dydrogesterone is as Tolerable and Safe as 600mg/Day 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 Know Which of the Two Treatments a Patient Receives (Lotus I)

This study is currently recruiting participants.
Verified January 2014 by Abbott
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01850030
First received: April 19, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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: August 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (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

  Eligibility

Ages Eligible for Study:   19 Years to 41 Years
Genders 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) 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:

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

Contacts
Contact: Esther Oppermann, PhD +4951167503954 esther.oppermann@abbott.com
Contact: Darline Cheatham-Seitz, PhD, MD +4951167502442 darline.cheatham-seitz@abbott.com

Locations
Austria
Site reference no. 113155 Not yet recruiting
Vienna, Austria, 1130
Site reference no. 113176 Not yet recruiting
Vienna, Austria, 1090
Belgium
Site reference no. 93593 Recruiting
Brasschaat, Belgium, 2930
Site reference no. 93615 Recruiting
Brussels, Belgium, 1090
Site reference no. 93598 Recruiting
Brussels, Belgium, 1070
Site reference no. 93617 Recruiting
Brussels, Belgium, 1200
Site reference no. 93613 Recruiting
Genk, Belgium, 3600
Site reference no. 93597 Recruiting
Gent, Belgium, 9000
Site reference no. 93594 Recruiting
Gent, Belgium, 9000
Site reference no. 93616 Recruiting
Hasselt, Belgium, 3500
Site reference no. 93595 Recruiting
Leuven, Belgium, 3000
Site reference no. 93614 Recruiting
Mons, Belgium, 7000
Israel
Site reference no. 93635 Not yet recruiting
Be'er Sheva, Israel, 84101
Site reference no. 93638 Not yet recruiting
Jerusalem, Israel, 9112001
Site reference no. 93641 Not yet recruiting
Tel Aviv, Israel, 69710
Russian Federation
Site reference no. 93642 Not yet recruiting
Moscow, Russian Federation, 127473
Site reference no. 119916 Not yet recruiting
St. Petersburg, Russian Federation, 191015
Spain
Site reference no. 119915 Not yet recruiting
Baracaldo, Vizcaya, Spain, 48903
Sponsors and Collaborators
Abbott
Quintiles
Investigators
Study Director: Darline Cheatham-Seitz, PhD, MD Abbott
  More Information

No publications provided

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: January 27, 2014
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
Infertility
Genital Diseases, Male
Genital Diseases, Female
Dydrogesterone
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014