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

Sponsor

Wolfson Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03832699

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
ART	Drug: Dydrogesterone 10 MG Drug: Endometrin 100Mg Vaginal Insert	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer: a Non-inferiority Randomized Clinical Trial

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral progesterone	Drug: Dydrogesterone 10 MG Oral progesterone 10 mg TID
Active Comparator: Vaginal progesterone	Drug: Endometrin 100Mg Vaginal Insert Vaginal Endometrin 100 mg twice daily

Arm

Intervention/Treatment

Experimental: Oral progesterone

Drug: Dydrogesterone 10 MG

Oral progesterone 10 mg TID

Active Comparator: Vaginal progesterone

Drug: Endometrin 100Mg Vaginal Insert

Vaginal Endometrin 100 mg twice daily

Outcome Measures

Primary Outcome Measures

Live birth rate [Up to 9 months]
Birth of a live infant after 24 weeks gestation

Secondary Outcome Measures

Clinical pregnancy rate [Outcome assesed 6-7 weeks following treatment]
Viable pregnancy as demonstrated by ultrasound
Implantation rate [Outcome assessed 6-7 weeks following treatment]
Number of gestational sacs divided by number of embryos transferred (percentage)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edith Wolfson Medical Center	Holon		Israel	5822012

Sponsors and Collaborators

Wolfson Medical Center

Investigators

Principal Investigator: Hadas Ganer Herman, MD, Edith Wolfson Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hadas Ganer Herman, Principal investigator, Wolfson Medical Center

ClinicalTrials.gov Identifier:

NCT03832699

Other Study ID Numbers:

0013-19-WOMC

First Posted:

Feb 6, 2019

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dydrogesterone

Progesterone

Study Results

No Results Posted as of Oct 8, 2020