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Clinical trialNCT02491437CompletedPhase 3Interventional

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)

SponsorAbbottEnrollment1,034Female Infertility
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

40 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Melbourne Ivf

    East Melbourne, Australia

  • Ivf Australia - St George Private Hospitalivf Australia - St George Private Hospital

    Kogarah, Australia

Belgium
  • Univerité Catholique de Louvain, Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Algemeen Ziekenhuis Jan Palfijn Gent

    Ghent, Belgium

  • Uz Gent

    Ghent, Belgium

  • Universitair Ziekenhuis Brussel

    Jette, Belgium

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, China

Germany
  • Fertility Center Berlin

    Berlin, Germany

  • Bielefeld Fertility Center

    Bielefeld, Germany

  • Kinderwunschzentrum Dortmund

    Dortmund, Germany

  • Universitäres Kinderwunschzentrum Lübeck

    Lübeck, Germany

Hong Kong
  • Queen Mary Hospital

    Hong Kong, 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, India

Russia
  • Cjsc "nasledniki"

    Moscow, Russia

  • Scientific Research Center of Obstetrics, Gynecology and Perinatology N. A. Ac. V. I. Kulakova

    Moscow, Russia

  • Saint-Petersburg State Budgetary Healtcare Institution "maternity Hospital # 17"

    Saint Petersburg, Russia

  • Cjsc "center of Family Medicine"

    Yekaterinburg, Russia

Singapore
  • Singapore General Hospital

    Singapore, Singapore

Thailand
  • Songklanagarind Hospital

    Bangkok, Thailand

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, Thailand

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, Ukraine

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DydrogesteroneIntravaginal progesterone gel 90 mg
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2015
Primary completion
31 May 2017
Completion
31 May 2017
Last update posted
1 Oct 2019
Registered enrollment
1,034
Registry id
NCT02491437

Cross-registrations

EU-CTR / CTIS (EudraCT)2012-002993-29

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.