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The Need for Luteal Support in NC-FET

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ClinicalTrials.gov Identifier: NCT01483365
Recruitment Status : Unknown
Verified June 2014 by Wolfson Medical Center.
Recruitment status was:  Recruiting
First Posted : December 1, 2011
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Wolfson Medical Center

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

Condition or disease Intervention/treatment Phase
Abnormal Menstrual Cycle Drug: Vaginal tablet Endometrin twice a day Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Use of Luteal Support After NC-FET
Study Start Date : December 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Vaginal tablet Endometrin twice a day
    Endometrin 100 mg twice a day
    Other Name: Endometrin 100 mg twice a day


Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 4 weeks ]
    We would like to investigate whether there is need for luteal support in NC-FET cycle.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01483365     History of Changes
Other Study ID Numbers: 0087-11-WOMC-
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014

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