Trial record 2 of 65 for:    Open Studies | "Menstruation Disturbances"

The Need for Luteal Support in NC-FET

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Wolfson Medical Center
Sponsor:
Information provided by (Responsible Party):
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01483365
First received: November 29, 2011
Last updated: June 15, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Abnormal Menstrual Cycle
Drug: Vaginal tablet Endometrin twice a day
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Use of Luteal Support After NC-FET

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    We would like to investigate whether there is need for luteal support in NC-FET cycle.


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vaginal tablet Endometrin twice a day
    Endometrin 100 mg twice a day
    Other Name: Endometrin 100 mg twice a day
Detailed Description:

The investigators are going to examine retroprospectively the need of luteal support after NC-FET in IVF cycle. One arm will receive luteal support after NC FET with vaginal tablet of Endometrin 100 mg twice a day after ET. The second arm will not. We are going to evaluate the pregnancy and implantation rate.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • NO
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483365

Contacts
Contact: Eran Horowitz, M.D 972-3-5028105 ERANH7@GMAIL.COM

Locations
Israel
Wolfson medical center Recruiting
Holon, Israel, 58100
Contact: Eran Horowitz, M.D    972-3-5028105    eranh7@gmail.com   
Sub-Investigator: Eran Horowitz, M.D         
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: David Levran, M.D IVF Unit, Department of Obstetrics and Gynecology,Wolfson Medical Center . Holon, Israel
  More Information

No publications provided

Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01483365     History of Changes
Other Study ID Numbers: 0087-11-WOMC-
Study First Received: November 29, 2011
Last Updated: June 15, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014