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)

Female Infertility Clinical Trial

— LOTUS II  

Official title:

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)

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
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: September 2019
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

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)