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

NCT ID: NCT03832699

Last Updated: 2020-10-08

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-10-31

Brief Summary

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The current trial is intended to assess the efficacy of oral versus vaginal progesterone for luteal support in frozen IVF cycles.

Detailed Description

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Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF. Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone in frozen IVF cycles.

Conditions

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ART

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral progesterone

Group Type EXPERIMENTAL

Dydrogesterone 10 MG

Intervention Type DRUG

Oral progesterone 10 mg TID

Vaginal progesterone

Group Type ACTIVE_COMPARATOR

Endometrin 100Mg Vaginal Insert

Intervention Type DRUG

Vaginal Endometrin 100 mg twice daily

Interventions

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Dydrogesterone 10 MG

Oral progesterone 10 mg TID

Intervention Type DRUG

Endometrin 100Mg Vaginal Insert

Vaginal Endometrin 100 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ages 18-39
* Modified natural cycle (induction of ovulation with HCG)
* Consent to participation

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hadas Ganer Herman

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hadas Ganer Herman, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

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Edith Wolfson Medical Center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hadas Ganer Herman, MD

Role: CONTACT

972526206696

Facility Contacts

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Hadas Ganer Herman, MD

Role: primary

9720526206696

Other Identifiers

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0013-19-WOMC

Identifier Type: -

Identifier Source: org_study_id

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