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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02491437
Other study ID # M13-625
Secondary ID 2012-002993-29
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2015
Est. completion date May 2017

Study information

Verified date September 2019
Source Abbott
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this randomized, two-arm and open label study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who are unable to conceive a child and are 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).


Description:

"This article has been accepted for publication in Human Reproduction published by Oxford University Press."


Recruitment information / eligibility

Status Completed
Enrollment 1034
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 41 Years
Eligibility 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 screening 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 at screening

- 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 or at 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 prior 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)

- Subject is not pregnant , confirmed by negative pregnancy or by Investigator Judgement

- 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 àny experimental drug or any 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 Acute urogenital disease

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dydrogesterone 30 mg
Oral Dydrogesterone 10 mg tablets tid
intravaginal progesterone gel 90 mg


Locations

Country Name City State
Australia Melbourne IVF East Melbourne
Australia IVF Australia - St George Private HospitalIVF Australia - St George Private Hospital Kogarah
Belgium Univerité Catholique de Louvain, Cliniques universitaires Saint-Luc Brussels
Belgium Algemeen Ziekenhuis Jan Palfijn Gent Gent
Belgium UZ Gent Gent
Belgium Universitair Ziekenhuis Brussel Jette
China Peking University People's Hospital Beijing
China Reproductive & Genetic Hospital of Citic -Xiangya Changsha
China West China Second University Hospital Chengdu
China Sun Yat-Sen Memorial Hsopiatl, Sun Yat-Sen University Guangzhou
China The Sixth Hospital of Sun Yat-Sen University Guangzhou
China The First Affiliate Hospital of Anhui Medical University Hefei
China The First Affiliated Hospital of Nanjing Medical University Nanjing
China Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan
China First Affiliated Hospital of Zhengzhou University Zhengzhou
Germany Fertility Center Berlin Berlin
Germany Bielefeld Fertility Center Bielefeld
Germany Kinderwunschzentrum Dortmund Dortmund
Germany Universitäres Kinderwunschzentrum Lübeck Lübeck
Hong Kong Queen Mary Hospital Hong Kong
India United CIIGMA Hospital Aurangabad
India Apollo Hospitals - Bangalore Bangalore
India MILANN (Bangalore Assisted Conception Center) Bangalore
India All India Institute of Medical Sciences Delhi
India Max Hospital Delhi
India Institute of Reproductive Medicine Kolkata
India Ajanta Research Center, Ajanta Hospital and IVF center Lucknow
India Inamdar Multispecialty Hospital Pune
India Shree Hospital and Diagnostic Centre Pune
Russian Federation CJSC "Center of Family Medicine" Ekaterinburg
Russian Federation CJSC "Nasledniki" Moscow
Russian Federation Scientific Research Center of Obstetrics, Gynecology and Perinatology n. a. Ac. V. I. Kulakova Moscow
Russian Federation Saint-Petersburg State Budgetary Healtcare Institution "Maternity Hospital # 17" Saint-Petersburg
Singapore Singapore General Hospital Singapore
Thailand Songklanagarind Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai Hospital Chiang Mai
Ukraine Medical Centre of Infertility Treatment "Clinic of Professor Yuzko" Chernivtsi
Ukraine "Mother and Child" clinic Kiev
Ukraine "NADIYA" Clinic Kiev
Ukraine The Institute for Reproductive Medicine in Ukraine Kiev

Sponsors (3)

Lead Sponsor Collaborator
Abbott Datamap, PRA Health Sciences

Countries where clinical trial is conducted

Australia,  Belgium,  China,  Germany,  Hong Kong,  India,  Russian Federation,  Singapore,  Thailand,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound Pregnancy rate defined as the presence of fetal heart beats at 12 weeks' gestation determined by transvaginal ultrasound. 12 weeks´ gestation
Secondary Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer) Positive biochemical pregnancy test on Day 14 after embryo transfer Day 14 after embryo transfer
Secondary Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth) Live birth rate (percentage of participants with a live birth) After delivery (about 9 months after IVF)
Secondary Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female) The gender (number of delivered newborns that are male or female) After delivery (about 9 months after IVF)
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