NCT03832699

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.6 years

First QC Date

February 5, 2019

Last Update Submit

October 6, 2020

Conditions

ART

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    Birth of a live infant after 24 weeks gestation

    Up to 9 months

Secondary Outcomes (2)

  • Clinical pregnancy rate

    Outcome assesed 6-7 weeks following treatment

  • Implantation rate

    Outcome assessed 6-7 weeks following treatment

Study Arms (2)

Oral progesterone

EXPERIMENTAL
Drug: Dydrogesterone 10 MG

Vaginal progesterone

ACTIVE COMPARATOR
Drug: Endometrin 100Mg Vaginal Insert

Interventions

Dydrogesterone 10 MGDRUG

Oral progesterone 10 mg TID

Oral progesterone
Endometrin 100Mg Vaginal InsertDRUG

Vaginal Endometrin 100 mg twice daily

Vaginal progesterone

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Wolfson Medical Center

Holon, 5822012, Israel

RECRUITING

MeSH Terms

Interventions

DydrogesteroneProgesterone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnenedionesPregnenesCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Hadas Ganer Herman, MD

    Edith Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadas Ganer Herman, MD

CONTACT

972526206696hadassganer@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 6, 2019

Study Start

March 1, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

IL(1)