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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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Female Infertility

Intervention: Dydrogesterone 30 mg (Drug); Micronized Progesterone 600 mg (Drug); Placebo progesterone (Drug); Placebo dydrogesterone (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Darline Cheatham-Seitz, MD, PhD, Study Director, Affiliation: Abbott

Summary

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pregnancy Rate

Secondary outcome:

Positive Pregnancy test rate

Rate of successful completion of pregnancy

Adverse Events

Status newborn

Adverse Events

Eligibility

Minimum age: 19 Years. Maximum age: 41 Years. Gender(s): Female.

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 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

Locations and Contacts

Site reference no. 113176, Vienna 1090, Austria

Site reference no. 93593, Brasschaat 2930, Belgium

Site reference no. 93598, Brussels 1070, Belgium

Site reference no. 93615, Brussels 1090, Belgium

Site reference no. 93617, Brussels 1200, Belgium

Site reference no. 93613, Genk 3600, Belgium

Site reference no. 93594, Gent 9000, Belgium

Site reference no. 93597, Gent 9000, Belgium

Site reference no. 93616, Hasselt 3500, Belgium

Site reference no. 93595, Leuven 3000, Belgium

Site reference no. 93614, Mons 7000, Belgium

Site reference ID ORG-000884, Helsinki 00180, Finland

Site reference ID ORG-000885, Jyväskylä 40100, Finland

Site reference no. ORG-000635, Oulu 90014, Finland

Site reference ID ORG-000795, Tampere 33100, Finland

Site reference no. ORG-000633, Turku 20520, Finland

Site reference ID ORG-000643, Berlin 14050, Germany

Site reference ID ORG-000645, Berlin 10117, Germany

Site reference ID ORG-000642, Dresden 01307, Germany

Site reference ID ORG-000644, Heidelberg 69120, Germany

Site reference ID ORG-000883, Luebeck 23562, Germany

Site reference no. 93635, Be'er Sheva 84101, Israel

Research facility ID ORG-000934, Hadera 38100, Israel

Research facility ID ORG-000935, Haifa 3339419, Israel

Site reference no. 93638, Jerusalem 91120, Israel

Site reference no. 93641, Tel Aviv 69710, Israel

Center of Family Medicine LC, Ekaterinburg 620043, Russian Federation

FSBI "Ural SRI of Maternity and Child Protection" of MoH and SD, Ekaterinburg 620028, Russian Federation

CJSC "Nasledniki", Moscow 119192, Russian Federation

FGBU Endocrinology Research Center of Minzdrav of Russia, Moscow 117036, Russian Federation

Moscow State Medical Dentistry University, Moscow 117036, Russian Federation

Moscow State Medical Dentistry University, Moscow 127473, Russian Federation

SBEIHPE - NWSMU n.a.l.l.Melnichko MoH and SD of RF, St. Petersburg 191014, Russian Federation

St. Petersburg SBHI "Maternity Hospital No 17" (main address), St. Petersburg 192174, Russian Federation

Site reference no. 119915, Baracaldo, Vizcaya 48903, Spain

Site reference ID ORG-000791, Barcelona 08017, Spain

Site reference no. ORG-000639, Bilbao 48940, Spain

Site reference no. ORG-000640, Pozuelo de Alarcon (Madrid) 28223, Spain

Site reference no. ORG-000638, Sevilla 41011, Spain

Site reference no. ORG-000637, Valencia 46015, Spain

Additional Information

Starting date: July 2013
Last updated: July 1, 2015

Page last updated: August 23, 2015

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