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

NCT ID: NCT01850030

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1070 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-03-31

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).

Conditions

Female Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dydrogesterone 30 mg

Group Type: EXPERIMENTAL

Dydrogesterone 30 mg

Intervention Type: DRUG

Oral Dydrogesterone 10 mg tablets tid

Placebo progesterone

Intervention Type: DRUG

Placebo intravaginal micronized progesterone 200 mg capsules tid

Micronized Progesterone 600 mg

Group Type: EXPERIMENTAL

Micronized Progesterone 600 mg

Intervention Type: DRUG

Intravaginal micronized progesterone 200 mg capsules tid

Placebo dydrogesterone

Intervention Type: DRUG

placebo oral dydrogesterone 10 mg tablets tid

Interventions

Dydrogesterone 30 mg

Oral Dydrogesterone 10 mg tablets tid

Intervention Type: DRUG

Micronized Progesterone 600 mg

Intravaginal micronized progesterone 200 mg capsules tid

Intervention Type: DRUG

Placebo progesterone

Placebo intravaginal micronized progesterone 200 mg capsules tid

Intervention Type: DRUG

Placebo dydrogesterone

placebo oral dydrogesterone 10 mg tablets tid

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darline Cheatham-Seitz, MD, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

Site reference no. 113176

Vienna, , Austria

Site reference no. 93593

Brasschaat, , Belgium

Site reference no. 93598

Brussels, , Belgium

Site reference no. 93615

Brussels, , Belgium

Site reference no. 93617

Brussels, , Belgium

Site reference no. 93613

Genk, , Belgium

Site reference no. 93594

Ghent, , Belgium

Site reference no. 93597

Ghent, , Belgium

Site reference no. 93616

Hasselt, , Belgium

Site reference no. 93595

Leuven, , Belgium

Site reference no. 93614

Mons, , Belgium

Site reference ID ORG-000884

Helsinki, , Finland

Site reference ID ORG-000885

Jyväskylä, , Finland

Site reference no. ORG-000635

Oulu, , Finland

Site reference ID ORG-000795

Tampere, , Finland

Site reference no. ORG-000633

Turku, , Finland

Site reference ID ORG-000645

Berlin, , Germany

Site reference ID ORG-000643

Berlin, , Germany

Site reference ID ORG-000642

Dresden, , Germany

Site reference ID ORG-000644

Heidelberg, , Germany

Site reference ID ORG-000883

Lübeck, , Germany

Site reference no. 93635

Beersheba, , Israel

Research facility ID ORG-000934

Hadera, , Israel

Research facility ID ORG-000935

Haifa, , Israel

Site reference no. 93638

Jerusalem, , Israel

Site reference no. 93641

Tel Aviv, , Israel

FGBU Endocrinology Research Center of Minzdrav of Russia

Moscow, , Russia

Moscow State Medical Dentistry University

Moscow, , Russia

CJSC "Nasledniki"

Moscow, , Russia

Moscow State Medical Dentistry University

Moscow, , Russia

SBEIHPE - NWSMU n.a.l.l.Melnichko MoH and SD of RF

Saint Petersburg, , Russia

St. Petersburg SBHI "Maternity Hospital No 17" (main address)

Saint Petersburg, , Russia

FSBI "Ural SRI of Maternity and Child Protection" of MoH and SD

Yekaterinburg, , Russia

Center of Family Medicine LC

Yekaterinburg, , Russia

Site reference no. 119915

Baracaldo, Vizcaya, , Spain

Site reference ID ORG-000791

Barcelona, , Spain

Site reference no. ORG-000639

Bilbao, , Spain

Site reference no. ORG-000640

Pozuelo de Alarcon (Madrid), , Spain

Site reference no. ORG-000638

Seville, , Spain

Site reference no. ORG-000637

Valencia, , Spain

Countries

Austria; Belgium; Finland; Germany; Israel; Russia; Spain

References

Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.

Reference Type: DERIVED

PMID: 28333318 (View on PubMed)

Other Identifiers

2012-002215-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-563

Identifier Type: -

Identifier Source: org_study_id