A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone versus Crinone intravaginal progesterone gel for Luteal Support in In-Vitro Fertilization (LOTUS II)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/01/006490
• Date of registration: 07-01-2016
• Prospective Registration: Yes
• Primary sponsor: Abbott Laboratories GmbH
• Public title: A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone versus Crinone intravaginal progesterone gel for Luteal Support in In-Vitro Fertilization (LOTUS II)
• Scientific 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) - Lotus II
• Date of first enrolment: 15-01-2016
• Target sample size: 1066
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13476
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 3/ Phase 4

Countries of recruitment

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

Contacts

• Name: DrBalagopal Nair
• Affiliation: Abbott India Limited

• Name: DrShubhangi Desai
• Affiliation: Abbott India Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1. Signed informed consent;

2. Premenopausal females, age > 18 years < 42 years

3. Non-smokers. For females who were past smokers, they must have

stopped tobacco usage for at least 3 months prior baseline visit

4. Early follicular phase (Day 2-4) FSH (Follicle stimulating hormone)

less than or equal to 15 IU/L and estradiol (E2)within normal limits

5. LH (luteinizing hormone), PRL (prolactin), T (testosterone) and TSH

(thyroid-stimulating hormone), within the normal limits for the clinical

laboratory, or considered not clinically significant by the Investigator

within 6 months prior to screening

6. 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)

7. Normal transvaginal ultrasound at screening (or within 14 days of

screening) without evidence of clinically significant abnormality

consistent with finding adequate for ART with respect to uterus and

adnexa (no hydrosalpinx or clinically relevant uterine fibroids)

8. Negative pregnancy test on the day of pituitary down regulation (prior

to administration of GnRH agonist or GnRH antagonist)

9. Clinically indicated protocol for induction of IVF with a fresh embryo

10. Single or dual embryo transfer

11. BMI >= 18 and <= 30 kg/m2
Exclusion criteria: 1.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

2.Acute urogenital disease

3.Known allergic reactions to progesterone products

4.Intake of experimental drug or any participation in any other clinical trial within 30 days prior to study start

5.Mental disability or any other lack of fitness, in the investigators opinion, to preclude subjects in or to complete the study

6.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)

7.History of chemotherapy

8.Patients with more than 3 unsuccessful IVF attempts

9.Contraindication for pregnancy

10.Refusal or inability to comply with the requirements of the study protocol for any reason,

including scheduled clinic visits and laboratory tests

11.History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Female infertility

Intervention(s)

Intervention1: Dydrogesterone tablets: Dose: 10 mg
Frequency: Three times a day
Duration: Until pregnancy is negative or until week 12 gestation
Route of administration: Oral
Control Intervention1: Crinone 8% intravaginal progesterone gel: Dose: 90 mg
Frequency: Once daily
Duration: Until pregnancy is negative or until week 12 gestation
Route of administration: Intra-vaginal

Primary Outcome(s)

Pregnancy rate defined as the presence of fetal heart beats at 12 weeksâ?? gestation determined by transvaginal ultrasound.Timepoint: Pregnancy rate defined as the presence of fetal heart beats at 12 weeksâ?? gestation determined by transvaginal ultrasound.

Secondary Outcome(s)

Adverse Events (Safety and Tolerability data (mother and child) )Timepoint: until Study Completion

Status Newborn (The gender, APGAR score, height, weight and head circumference, physical examination and any malformations of the newborn(s) will be recorded.)Timepoint: After delivery (about 9 months after IVF)

Positive biochemical pregnancy test on Day 14 after embryo transferTimepoint: Day 14 after embryo transfer

Rate of successful completion of pregnancy (Incidence of live births and healthy newborns)Timepoint: After delivery (about 9 months after IVF)

Secondary ID(s)

M13-625

NIL

Source(s) of Monetary Support

Abbott Laboratories GmbH

Ethics review

Status: Approved
Approval date: 25/08/2015
Contact:

Ethics Committee Kodlikeri Memorial Hospital and CIIGMA Hospital

Status: Approved
Approval date: 30/08/2015
Contact:

Ethics Committee, Ajanta Hospital and IVF Centre

Status: Approved
Approval date: 09/10/2015
Contact:

Ethics Committee, Inamdar Hospital

Status: Approved
Approval date: 16/11/2015
Contact:

Max Healthcare Ethics Committee

Status: Approved
Approval date: 20/11/2015
Contact:

Institute Ethics Committee All india Institute of medical sciences

Status: Approved
Approval date: 15/12/2015
Contact:

The Ethics Committee of Shree Hospital

Status: Approved
Approval date: 02/03/2016
Contact:

Institutional Ethics Commitee, Apollo Hospitals

Status: Approved
Approval date: 06/04/2016
Contact:

IIRRH-BACC Healthcare Institutional Ethics Committee