A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)
LOTUS II
A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)
2 other identifiers
interventional
1,034
10 countries
40
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2015
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
October 1, 2019
CompletedOctober 1, 2019
September 1, 2019
1.8 years
June 16, 2015
July 9, 2019
September 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer)
Day 14 after embryo transfer
Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth)
After delivery (about 9 months after IVF)
Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female)
After delivery (about 9 months after IVF)
Study Arms (2)
Dydrogesterone tablets 3x10 mg
EXPERIMENTALDydrogesterone tablets 3x10 mg
Crinone 8% intravaginal progesterone gel 90 mg
EXPERIMENTALCrinone 8% intravaginal progesterone gel 90 mg
Interventions
Eligibility Criteria
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 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
- PRA Health Sciencescollaborator
- Datamapcollaborator
Study Sites (40)
Melbourne IVF
East Melbourne, 3002, Australia
IVF Australia - St George Private HospitalIVF Australia - St George Private Hospital
Kogarah, 2217, Australia
Univerité Catholique de Louvain, Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Algemeen Ziekenhuis Jan Palfijn Gent
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
Peking University People's Hospital
Beijing, 100044, China
Reproductive & Genetic Hospital of Citic -Xiangya
Changsha, 410008, China
West China Second University Hospital
Chengdu, 610041, China
Sun Yat-Sen Memorial Hsopiatl, Sun Yat-Sen University
Guangzhou, 510120, China
The Sixth Hospital of Sun Yat-Sen University
Guangzhou, 510655, China
The First Affiliate Hospital of Anhui Medical University
Hefei, 230022, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, 430030, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Fertility Center Berlin
Berlin, 14050, Germany
Bielefeld Fertility Center
Bielefeld, 33619, Germany
Kinderwunschzentrum Dortmund
Dortmund, 44135, Germany
Universitäres Kinderwunschzentrum Lübeck
Lübeck, 23538, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
United CIIGMA Hospital
Aurangabad, 431005, India
MILANN (Bangalore Assisted Conception Center)
Bangalore, 560001, India
Apollo Hospitals - Bangalore
Bangalore, 560076, India
All India Institute of Medical Sciences
Delhi, 110029, India
Max Hospital
Delhi, 110057, India
Institute of Reproductive Medicine
Kolkata, 700014, India
Ajanta Research Center, Ajanta Hospital and IVF center
Lucknow, 226005, India
Inamdar Multispecialty Hospital
Pune, 411002, India
Shree Hospital and Diagnostic Centre
Pune, 411006, India
Scientific Research Center of Obstetrics, Gynecology and Perinatology n. a. Ac. V. I. Kulakova
Moscow, 117997, Russia
CJSC "Nasledniki"
Moscow, 119192, Russia
Saint-Petersburg State Budgetary Healtcare Institution "Maternity Hospital # 17"
Saint Petersburg, 193174, Russia
CJSC "Center of Family Medicine"
Yekaterinburg, 620043, Russia
Singapore General Hospital
Singapore, 169608, Singapore
Songklanagarind Hospital
Bangkok, 90110, Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200, Thailand
Medical Centre of Infertility Treatment "Clinic of Professor Yuzko"
Chernivtsi, 58022, Ukraine
"NADIYA" Clinic
Kiev, 03037, Ukraine
The Institute for Reproductive Medicine in Ukraine
Kiev, 04107, Ukraine
"Mother and Child" clinic
Kiev, 0411, Ukraine
Related Publications (1)
Griesinger G, Blockeel C, Sukhikh GT, Patki A, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, Tournaye H. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306.
PMID: 30304457DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Erik van Leeuwen MSc, PMP
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Shreyansh Shah, MD
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2015
First Posted
July 8, 2015
Study Start
July 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
October 1, 2019
Results First Posted
October 1, 2019
Record last verified: 2019-09