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

ART Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03832699
• Other study ID #: 0013-19-WOMC
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: October 2021

Study information

• Verified date: October 2020
• Source: Wolfson Medical Center
• Contact: Hadas Ganer Herman, MD
• Phone: 972526206696
• Email: hadassganer[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Ages 18-39

• Modified natural cycle (induction of ovulation with HCG)

• Consent to participation

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• ART

Intervention

Drug:
• Dydrogesterone 10 MG
Oral progesterone 10 mg TID
• Endometrin 100Mg Vaginal Insert
Vaginal Endometrin 100 mg twice daily

Locations

Country	Name	City	State
Israel	Edith Wolfson Medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Birth of a live infant after 24 weeks gestation	Up to 9 months
Secondary	Clinical pregnancy rate	Viable pregnancy as demonstrated by ultrasound	Outcome assesed 6-7 weeks following treatment
Secondary	Implantation rate	Number of gestational sacs divided by number of embryos transferred (percentage)	Outcome assessed 6-7 weeks following treatment