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Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles

Sponsor
Memorial Sisli Hospital, Istanbul (Other)
Overall Status
Unknown status
CT.gov ID
NCT04124913
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
10.9
Anticipated Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this randomized controlled trial is to compare the efficacy of oral dydrogesterone vs. micronized vaginal progesterone for luteal phase support in frozen-thawed embryo transfer cycles.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dydrogesterone 10 MG Oral Tablet
  • Drug: Progesterone Vaginal Gel [Crinone]
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial
Actual Study Start Date :
Jan 2, 2019
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dydrogesterone

Drug: Dydrogesterone 10 MG Oral Tablet
Oral dydrogesterone 10 mg tablet three times a day for luteal phase support
Other Names:
  • Duphaston

    		•
    Active Comparator: Vaginal progesterone

    Drug: Progesterone Vaginal Gel [Crinone]
    Vaginal progesterone gel 90 mg once a day for luteal phase support
    Other Names:
  • Crinone %8 vaginal progesterone gel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ongoing pregnancy rate [12 weeks after the last menstrual period of the patient]

      Presence of at least one live fetus at the end of the 12th gestational week

    Secondary Outcome Measures

    1. Clinical pregnancy rate [6-7 weeks after the last menstrual period of the patient]

      Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation

    2. Implantation rate [5 weeks after the last menstrual period of the patient]

      Percentage of gestational sacs compared to the number of embryos transferred

    3. Biochemical pregnancy [10 days after embryo transfer]

      Positive serum beta HCG test performed 10 days after embryo transfer

    4. Biochemical miscarriage [before 5th gestational week]

      pregnancy loss before ultrasonographic detection of an intrauterine gestational sac

    5. Clinical miscarriage [after 5th gestational week]

      pregnancy loss after ultrasonographic detection of an intrauterine gestational sac

    6. headache rate [6-7 weeks after the last menstrual period of the patient]

    7. interference with coitus rate [6-7 weeks after the last menstrual period of the patient]

    8. somnolence rate [6-7 weeks after the last menstrual period of the patient]

    9. dizziness rate [6-7 weeks after the last menstrual period of the patient]

    10. nausea/vomiting rate [6-7 weeks after the last menstrual period of the patient]

    11. vaginal discharge rate [6-7 weeks after the last menstrual period of the patient]

    12. perineal irritation rate [6-7 weeks after the last menstrual period of the patient]

    13. abdominal pain rate [6-7 weeks after the last menstrual period of the patient]

    14. mastalgia rate [6-7 weeks after the last menstrual period of the patient]

    15. vaginal bleeding rate [6-7 weeks after the last menstrual period of the patient]

    16. interference with intercourse rate [6-7 weeks after the last menstrual period of the patient]

    17. overall satisfaction score [6-7 weeks after the last menstrual period of the patient]

      patient satisfaction from the drug used measured on a 1-5 scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Ages between 20 and 40

    • Modified natural frozen- thawed embryo transfer cycles

    Exclusion Criteria:

    • Recurrent implantation failure

    • Recurrent pregnancy loss

    • Presence of uterine pathology

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Şişli Hospital Istanbul Şişli Turkey 34385

    Sponsors and Collaborators

    • Memorial Sisli Hospital, Istanbul

    Investigators

    • Principal Investigator: Semra Kahraman, Prof, Memorial Şişli Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gönül Özer, Medical doctor, Memorial Sisli Hospital, Istanbul
    ClinicalTrials.gov Identifier:
    NCT04124913
    Other Study ID Numbers:
    • 2019/001
    First Posted:
    Oct 14, 2019
    Last Update Posted:
    Oct 14, 2019
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Gönül Özer, Medical doctor, Memorial Sisli Hospital, Istanbul
    oral dydrogesterone
    luteal phase support
    vaginal progesterone gel
    frozen-thawed embryo transfer
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Infertility, Male
    Progesterone
    Dydrogesterone

    Study Results

    No Results Posted as of Oct 14, 2019