AzTrials
AzTrials

Female InfertilityPhase 3Lotus INCT01850030

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

A Phase 3 study testing Dydrogesterone 30 mg and Micronized Progesterone 600 mg in people with Female Infertility, run by Abbott at 40 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 19 to 41 years, women only
Conditions the study is for
Female Infertility
What is being tested?
Dydrogesterone 30 mg and Micronized Progesterone 600 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,070 participants
Where
40 sitesin 7 countries
Study dates
Aug 2013to Mar 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 41 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

40 sites in 7 countries.

40 sites in 7 countries

Belgium10 sites

  • Site reference no. 93593

    Brasschaat, 2930

  • Site reference no. 93598

    Brussels, 1070

  • Site reference no. 93615

    Brussels, 1090

  • Site reference no. 93617

    Brussels, 1200

  • Site reference no. 93613

    Genk, 3600

  • Site reference no. 93594

    Ghent, 9000

  • Site reference no. 93597

    Ghent, 9000

  • Site reference no. 93616

    Hasselt, 3500

  • Site reference no. 93595

    Leuven, 3000

  • Site reference no. 93614

    Mons, 7000

Other trials in Belgium

Russia8 sites

  • FGBU Endocrinology Research Center of Minzdrav of Russia

    Moscow, 117036

  • Moscow State Medical Dentistry University

    Moscow, 117036

  • CJSC "Nasledniki"

    Moscow, 119192

  • Moscow State Medical Dentistry University

    Moscow, 127473

  • SBEIHPE - NWSMU n.a.l.l.Melnichko MoH and SD of RF

    Saint Petersburg, 191014

  • St. Petersburg SBHI "Maternity Hospital No 17" (main address)

    Saint Petersburg, 192174

  • FSBI "Ural SRI of Maternity and Child Protection" of MoH and SD

    Yekaterinburg, 620028

  • Center of Family Medicine LC

    Yekaterinburg, 620043

Other trials in Russia

Spain6 sites

  • Site reference no. 119915

    Baracaldo, Vizcaya, 48903

  • Site reference ID ORG-000791

    Barcelona, 08017

  • Site reference no. ORG-000639

    Bilbao, 48940

  • Site reference no. ORG-000640

    Pozuelo de Alarcon (Madrid), 28223

  • Site reference no. ORG-000638

    Seville, 41011

  • Site reference no. ORG-000637

    Valencia, 46015

Other trials in Spain

Finland5 sites

  • Site reference ID ORG-000884

    Helsinki, 00180

  • Site reference ID ORG-000885

    Jyväskylä, 40100

  • Site reference no. ORG-000635

    Oulu, 90014

  • Site reference ID ORG-000795

    Tampere, 33100

  • Site reference no. ORG-000633

    Turku, 20520

Other trials in Finland

Germany5 sites

  • Site reference ID ORG-000645

    Berlin, 10117

  • Site reference ID ORG-000643

    Berlin, 14050

  • Site reference ID ORG-000642

    Dresden, 01307

  • Site reference ID ORG-000644

    Heidelberg, 69120

  • Site reference ID ORG-000883

    Lübeck, 23562

Other trials in Germany

Israel5 sites

  • Site reference no. 93635

    Beersheba, 84101

  • Research facility ID ORG-000934

    Hadera, 38100

  • Research facility ID ORG-000935

    Haifa, 3339419

  • Site reference no. 93638

    Jerusalem, 91120

  • Site reference no. 93641

    Tel Aviv, 69710

Other trials in Israel

Austria1 site

  • Site reference no. 113176

    Vienna, 1090

Other trials in Austria

About this study

Official title: 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).

Being tested
Dydrogesterone 30 mg, Micronized Progesterone 600 mg, Placebo progesterone, Placebo dydrogesterone
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dydrogesterone 30 mgDrug

    Oral Dydrogesterone 10 mg tablets tid

  • Micronized Progesterone 600 mgDrug

    Intravaginal micronized progesterone 200 mg capsules tid

  • Placebo progesteroneDrug

    Placebo intravaginal micronized progesterone 200 mg capsules tid

  • Placebo dydrogesteroneDrug

    placebo oral dydrogesterone 10 mg tablets tid

Study groups in NCT01850030
Study groupRoleWhat they receive
Dydrogesterone 30 mgExperimentalNot described
Receives: Drug: Dydrogesterone 30 mg; Drug: Placebo progesterone
Micronized Progesterone 600 mgExperimentalNot described
Receives: Drug: Micronized Progesterone 600 mg; Drug: Placebo dydrogesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound

    Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound

    Measured: 12 weeks´ gestation (at visit 6)

Secondary outcomes (3)

  1. Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer

    Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer

    Measured: Day 14 after embryo transfer

  2. Percentage of Participants With a Successful Completion of Pregnancy

    Incidence of live births and healthy newborns

    Measured: After delivery (about 9 months after IVF)

  3. Gender of the Newborn

    was recorded and collected for Newborn

    Measured: After delivery (about 9 months after IVF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,070 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01850030
Sponsor's protocol ID
M13-563
Other IDs
2012-002215-26
Acronym
Lotus I
Status last verified
May 2017
First submitted
19 Apr 2013
Last updated
2 Jan 2018
Data monitoring committee
No

Publications

  • Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023.

    PubMed 28333318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dydrogesterone 30 mg and Micronized Progesterone 600 mg in people with Female Infertility, run by Abbott at 40 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Belgium, Russia, Spain, Finland, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01850030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.

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