NCT01483365

Brief Summary

The investigators are going to examine prospectively the need of luteal support after NC-FET.

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 P75+ for early_phase_1

Timeline
Completed

Started Dec 2011

Typical duration for early_phase_1

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

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

3 years

First QC Date

November 29, 2011

Last Update Submit

June 15, 2014

Conditions

Abnormal Menstrual Cycle

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    We would like to investigate whether there is need for luteal support in NC-FET cycle.

    4 weeks

Interventions

Vaginal tablet Endometrin twice a dayDRUG

Endometrin 100 mg twice a day

Also known as: Endometrin 100 mg twice a day

Eligibility Criteria

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

You may qualify if:

  • Women under 39 years old, regular menstruation going through IVF NC-FET

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson medical center

Holon, 58100, Israel

RECRUITING

Related Publications (1)

  • Horowitz E, Mizrachi Y, Finkelstein M, Farhi J, Shalev A, Gold E, Raziel A, Weissman A. A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle - frozen embryo transfer. Gynecol Endocrinol. 2021 Sep;37(9):792-797. doi: 10.1080/09513590.2020.1854717. Epub 2020 Dec 14.

    PMID: 33307906DERIVED

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • David Levran, M.D

    IVF Unit, Department of Obstetrics and Gynecology,Wolfson Medical Center . Holon, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Horowitz, M.D

CONTACT

972-3-5028105ERANH7@GMAIL.COM

Study Design

Study Type
interventional
Phase
early phase 1
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

IL(1)