Oral Dydrogesterone vs. Vaginal Micronized Progesterone f... | NCT03832699

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

NCT03832699

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Oct 8, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Interventions

Dydrogesterone 10 MG
Endometrin 100Mg Vaginal Insert

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Oct 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Feb 5, 2019

First Submission Date that Met QC Criteria

Feb 5, 2019

First Posted Date

Feb 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hadas Ganer Herman, Principal investigator, Wolfson Medical CenterPrincipal Investigator

Lead Sponsor

Wolfson Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral progesterone	Experimental		Drug: Dydrogesterone 10 MG
Vaginal progesterone	Active Comparator		Drug: Endometrin 100Mg Vaginal Insert

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dydrogesterone 10 MG	Drug	Oral progesterone 10 mg TID	Oral progesterone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Live birth rate	Birth of a live infant after 24 weeks gestation	Up to 9 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hadas Ganer Herman, MD	Contact	972526206696		hadassganer@yahoo.com

Overall Officials

Name	Affiliation	Role
Hadas Ganer Herman, MD	Edith Wolfson Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Edith Wolfson Medical Center	Recruiting	Holon		5822012	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D004394	Dydrogesterone
D011374	Progesterone

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided