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

NCT01850030 | Completed Phase 3 Results

• 2 other identifiers: M13-5632012-002215-26
• Study Type: interventional
• Target: 1,070
• Locations: 7 countries
• Sites: 40

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound

  Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound

  12 weeks´ gestation (at visit 6)

Secondary Outcomes (3)

• Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer

  Day 14 after embryo transfer

• Percentage of Participants With a Successful Completion of Pregnancy

  After delivery (about 9 months after IVF)

• Gender of the Newborn

  After delivery (about 9 months after IVF)

Study Arms (2)

Dydrogesterone 30 mg

EXPERIMENTAL

Drug: Dydrogesterone 30 mg; Drug: Placebo progesterone

Micronized Progesterone 600 mg

EXPERIMENTAL

Drug: Micronized Progesterone 600 mg; Drug: Placebo dydrogesterone

Interventions

Dydrogesterone 30 mg DRUG

Oral Dydrogesterone 10 mg tablets tid

Dydrogesterone 30 mg

Micronized Progesterone 600 mg DRUG

Intravaginal micronized progesterone 200 mg capsules tid

Micronized Progesterone 600 mg

Placebo progesterone DRUG

Placebo intravaginal micronized progesterone 200 mg capsules tid

Dydrogesterone 30 mg

Placebo dydrogesterone DRUG

placebo oral dydrogesterone 10 mg tablets tid

Micronized Progesterone 600 mg

Eligibility Criteria

• Age: 19 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead
• Quintiles, Inc.: collaborator

Study Sites (40)

Site reference no. 113176

Vienna, 1090, Austria

Location

Site reference no. 93593

Brasschaat, 2930, Belgium

Location

Site reference no. 93598

Brussels, 1070, Belgium

Location

Site reference no. 93615

Brussels, 1090, Belgium

Location

Site reference no. 93617

Brussels, 1200, Belgium

Location

Site reference no. 93613

Genk, 3600, Belgium

Location

Site reference no. 93594

Ghent, 9000, Belgium

Location

Site reference no. 93597

Ghent, 9000, Belgium

Location

Site reference no. 93616

Hasselt, 3500, Belgium

Location

Site reference no. 93595

Leuven, 3000, Belgium

Location

Site reference no. 93614

Mons, 7000, Belgium

Location

Site reference ID ORG-000884

Helsinki, 00180, Finland

Location

Site reference ID ORG-000885

Jyväskylä, 40100, Finland

Location

Site reference no. ORG-000635

Oulu, 90014, Finland

Location

Site reference ID ORG-000795

Tampere, 33100, Finland

Location

Site reference no. ORG-000633

Turku, 20520, Finland

Location

Site reference ID ORG-000645

Berlin, 10117, Germany

Location

Site reference ID ORG-000643

Berlin, 14050, Germany

Location

Site reference ID ORG-000642

Dresden, 01307, Germany

Location

Site reference ID ORG-000644

Heidelberg, 69120, Germany

Location

Site reference ID ORG-000883

Lübeck, 23562, Germany

Location

Site reference no. 93635

Beersheba, 84101, Israel

Location

Research facility ID ORG-000934

Hadera, 38100, Israel

Location

Research facility ID ORG-000935

Haifa, 3339419, Israel

Location

Site reference no. 93638

Jerusalem, 91120, Israel

Location

Site reference no. 93641

Tel Aviv, 69710, Israel

Location

FGBU Endocrinology Research Center of Minzdrav of Russia

Moscow, 117036, Russia

Location

Moscow State Medical Dentistry University

Moscow, 117036, Russia

Location

CJSC "Nasledniki"

Moscow, 119192, Russia

Location

Moscow State Medical Dentistry University

Moscow, 127473, Russia

Location

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

Saint Petersburg, 191014, Russia

Location

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

Saint Petersburg, 192174, Russia

Location

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

Yekaterinburg, 620028, Russia

Location

Center of Family Medicine LC

Yekaterinburg, 620043, Russia

Location

Site reference no. 119915

Baracaldo, Vizcaya, 48903, Spain

Location

Site reference ID ORG-000791

Barcelona, 08017, Spain

Location

Site reference no. ORG-000639

Bilbao, 48940, Spain

Location

Site reference no. ORG-000640

Pozuelo de Alarcon (Madrid), 28223, Spain

Location

Site reference no. ORG-000638

Seville, 41011, Spain

Location

Site reference no. ORG-000637

Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 28333318 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Dydrogesterone; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Erik van Leeuwen MSc, PMP
• Organization: Abbott

erik.vanleeuwen@abbott.com

+31294479241

Study Officials

• Darline Cheatham-Seitz, MD, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 9, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 2, 2018
• Results First Posted: January 2, 2018

Record last verified: 2017-05

Locations

IL (5); FI (5); DE (5); BE (10); AU (1); RU (8); ES (6)