NCT04124913

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

October 10, 2019

Last Update Submit

October 10, 2019

Conditions

Infertility, FemaleInfertility, MaleEmbryo TransferFertilization in VitroDrug EffectReproductive Techniques, AssistedProgesteroneDydrogesterone

Keywords

oral dydrogesteroneluteal phase supportvaginal progesterone gelfrozen-thawed embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

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

    12 weeks after the last menstrual period of the patient

Secondary Outcomes (17)

  • Clinical pregnancy rate

    6-7 weeks after the last menstrual period of the patient

  • Implantation rate

    5 weeks after the last menstrual period of the patient

  • Biochemical pregnancy

    10 days after embryo transfer

  • Biochemical miscarriage

    before 5th gestational week

  • Clinical miscarriage

    after 5th gestational week

  • +12 more secondary outcomes

Study Arms (2)

Dydrogesterone

EXPERIMENTAL
Drug: Dydrogesterone 10 MG Oral Tablet

Vaginal progesterone

ACTIVE COMPARATOR
Drug: Progesterone Vaginal Gel [Crinone]

Interventions

Dydrogesterone 10 MG Oral TabletDRUG

Oral dydrogesterone 10 mg tablet three times a day for luteal phase support

Also known as: Duphaston
Dydrogesterone
Progesterone Vaginal Gel [Crinone]DRUG

Vaginal progesterone gel 90 mg once a day for luteal phase support

Also known as: Crinone %8 vaginal progesterone gel
Vaginal progesterone

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages between 20 and 40
  • Modified natural frozen- thawed embryo transfer cycles

You may not qualify if:

  • Recurrent implantation failure
  • Recurrent pregnancy loss
  • Presence of uterine pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Şişli Hospital

Istanbul, Şişli, 34385, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility, FemaleInfertility, MaleHelping Behavior

Interventions

DydrogesteroneTabletsCrinone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityGenital Diseases, MaleMale Urogenital DiseasesSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Semra Kahraman, Prof

    Memorial Şişli Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonul Ozer, MD

CONTACT

+905326945549drgonulozer@gmail.com

Kadriye B Yuksel, MD

CONTACT

+905438852666berilyuksel@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

January 2, 2019

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

October 14, 2019

Record last verified: 2019-10

Locations

TU(1)