A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization (Lotus I)

May 31, 2017 updated by: Abbott

A Double-Blind, Double-Dummy, Randomized, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization (Lotus I)

Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients 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 after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1070

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Site reference no. 113176
  • Belgium
      • Brasschaat, Belgium, 2930
        • Site reference no. 93593
      • Brussels, Belgium, 1070
        • Site reference no. 93598
      • Brussels, Belgium, 1090
        • Site reference no. 93615
      • Brussels, Belgium, 1200
        • Site reference no. 93617
      • Genk, Belgium, 3600
        • Site reference no. 93613
      • Gent, Belgium, 9000
        • Site reference no. 93594
      • Gent, Belgium, 9000
        • Site reference no. 93597
      • Hasselt, Belgium, 3500
        • Site reference no. 93616
      • Leuven, Belgium, 3000
        • Site reference no. 93595
      • Mons, Belgium, 7000
        • Site reference no. 93614
  • Finland
      • Helsinki, Finland, 00180
        • Site reference ID ORG-000884
      • Jyväskylä, Finland, 40100
        • Site reference ID ORG-000885
      • Oulu, Finland, 90014
        • Site reference no. ORG-000635
      • Tampere, Finland, 33100
        • Site reference ID ORG-000795
      • Turku, Finland, 20520
        • Site reference no. ORG-000633
  • Germany
      • Berlin, Germany, 10117
        • Site reference ID ORG-000645
      • Berlin, Germany, 14050
        • Site reference ID ORG-000643
      • Dresden, Germany, 01307
        • Site reference ID ORG-000642
      • Heidelberg, Germany, 69120
        • Site reference ID ORG-000644
      • Luebeck, Germany, 23562
        • Site reference ID ORG-000883
  • Israel
      • Be'er Sheva, Israel, 84101
        • Site reference no. 93635
      • Hadera, Israel, 38100
        • Research facility ID ORG-000934
      • Haifa, Israel, 3339419
        • Research facility ID ORG-000935
      • Jerusalem, Israel, 91120
        • Site reference no. 93638
      • Tel Aviv, Israel, 69710
        • Site reference no. 93641
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620028
        • FSBI "Ural SRI of Maternity and Child Protection" of MoH and SD
      • Ekaterinburg, Russian Federation, 620043
        • Center of Family Medicine LC
      • Moscow, Russian Federation, 117036
        • FGBU Endocrinology Research Center of Minzdrav of Russia
      • Moscow, Russian Federation, 117036
        • Moscow State Medical Dentistry University
      • Moscow, Russian Federation, 119192
        • CJSC "Nasledniki"
      • Moscow, Russian Federation, 127473
        • Moscow State Medical Dentistry University
      • St. Petersburg, Russian Federation, 191014
        • SBEIHPE - NWSMU n.a.l.l.Melnichko MoH and SD of RF
      • St. Petersburg, Russian Federation, 192174
        • St. Petersburg SBHI "Maternity Hospital No 17" (main address)
  • Spain
      • Baracaldo, Vizcaya, Spain, 48903
        • Site reference no. 119915
      • Barcelona, Spain, 08017
        • Site reference ID ORG-000791
      • Bilbao, Spain, 48940
        • Site reference no. ORG-000639
      • Pozuelo de Alarcon (Madrid), Spain, 28223
        • Site reference no. ORG-000640
      • Sevilla, Spain, 41011
        • Site reference no. ORG-000638
      • Valencia, Spain, 46015
        • Site reference no. ORG-000637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 baseline 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
  • 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 to 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 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)
  • Negative pregnancy test on the day of pituitary down regulation (prior to administration of gonadotropin releasing hormones (GnRH) agonist or GnRH antagonist)
  • 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, head, ears, eyes, nose, throat (HEENT), 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 experimental drug or 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dydrogesterone 30 mg
Drug: Dydrogesterone 30 mg
Oral Dydrogesterone 10 mg tablets tid
Drug: Placebo progesterone
Placebo intravaginal micronized progesterone 200 mg capsules tid
Experimental: Micronized Progesterone 600 mg
Drug: Micronized Progesterone 600 mg
Intravaginal micronized progesterone 200 mg capsules tid
Drug: Placebo dydrogesterone
placebo oral dydrogesterone 10 mg tablets tid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound
Time Frame: 12 weeks´ gestation (at visit 6)
Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound
12 weeks´ gestation (at visit 6)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer
Time Frame: Day 14 after embryo transfer
Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer
Day 14 after embryo transfer
Percentage of Participants With a Successful Completion of Pregnancy
Time Frame: After delivery (about 9 months after IVF)
Incidence of live births and healthy newborns
After delivery (about 9 months after IVF)
Gender of the Newborn
Time Frame: After delivery (about 9 months after IVF)
was recorded and collected for Newborn
After delivery (about 9 months after IVF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Quintiles, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Darline Cheatham-Seitz, MD, PhD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M13-563
  • 2012-002215-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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