A randomized multicentre study comparing the effectiveness, safety and tolerance of daily oral dygesterone against Crinone gel for use in in-vitro fertilization (IVF)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002993-29-BE

Enrollment

1066

Registered

2015-05-19

Start date

2015-07-15

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment for the luteal support in in-vitro fertilization (IVF). MedDRA version: 18.1 Level: LLT Classification code 10021572 Term: In vitro fertilization System Organ Class: 100000004865

Interventions

Trade Name: Duphaston Product Name: Dydrogesterone Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DYDROGESTERONE CAS Number: 152-62-5 Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Signed informed consent 2.Premenopausal females, age > 18 years =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 Investigator's 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Demonstrate non-inferiority of oral dydrogesterone in the two treatment regimens versus micronized progesterone vaginal gel. The primary efficacy parameter is the presence of fetal heart beats at 12 weeks’gestation (10 weeks´ pregnancy) determined by transvaginal ultrasound. To obtain safety and tolerability data by means of documenting treatment emergent AEs.;Secondary Objective: The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer and the incidence of live births and healthy newborns. ;Primary end point(s): The primary efficacy parameter is the pregnancy rate ;Timepoint(s) of evaluation of this end point: Defined as the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound	—

Measure

Time frame

Main Objective: Demonstrate non-inferiority of oral dydrogesterone in the two treatment regimens versus micronized progesterone vaginal gel. The primary efficacy parameter is the presence of fetal heart beats at 12 weeks’gestation (10 weeks´ pregnancy) determined by transvaginal ultrasound. To obtain safety and tolerability data by means of documenting treatment emergent AEs.;Secondary Objective: The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer and the incidence of live births and healthy newborns. ;Primary end point(s): The primary efficacy parameter is the pregnancy rate ;Timepoint(s) of evaluation of this end point: Defined as the presence of fetal heart beats at 12 weeks’ gestation determined by transvaginal ultrasound

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer and the incidence of live births and healthy newborns.;Timepoint(s) of evaluation of this end point: The secondary parameters are a positive pregnancy test on Day 14 after embryo transfer and the incidence of live births and healthy newborns.	—

Countries

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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026