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

NCT ID: NCT04124913

Last Updated: 2019-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-02

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility, Female Infertility, Male Embryo Transfer Fertilization in Vitro Drug Effect Reproductive Techniques, Assisted Progesterone Dydrogesterone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dydrogesterone

Group Type EXPERIMENTAL

Dydrogesterone 10 MG Oral Tablet

Intervention Type DRUG

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

Vaginal progesterone

Group Type ACTIVE_COMPARATOR

Progesterone Vaginal Gel [Crinone]

Intervention Type DRUG

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

Interventions

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Dydrogesterone 10 MG Oral Tablet

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

Intervention Type DRUG

Progesterone Vaginal Gel [Crinone]

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

Intervention Type DRUG

Other Intervention Names

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Duphaston Crinone %8 vaginal progesterone gel

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Memorial Sisli Hospital, Istanbul

OTHER

Sponsor Role lead

Responsible Party

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Gönül Özer

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semra Kahraman, Prof

Role: PRINCIPAL_INVESTIGATOR

Memorial Şişli Hospital

Locations

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Memorial Şişli Hospital

Istanbul, Şişli, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gonul Ozer, MD

Role: CONTACT

+905326945549

Kadriye B Yuksel, MD

Role: CONTACT

+905438852666

Facility Contacts

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Gonul Ozer, MD

Role: primary

+905326945549

Kadriye B Yuksel, Assoc. Prof.

Role: backup

+905438852666

Other Identifiers

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2019/001

Identifier Type: -

Identifier Source: org_study_id

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