The Need for Luteal Support in NC-FET

Abnormal Menstrual Cycle Clinical Trial

Official title:

The Use of Luteal Support After NC-FET

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01483365
• Other study ID #: 0087-11-WOMC-
• Status: Recruiting
• Phase: Phase 0
• First received: November 29, 2011
• Last updated: June 15, 2014
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2014
• Source: Wolfson Medical Center
• Contact: Eran Horowitz, M.D
• Phone: 972-3-5028105
• Email: ERANH7[@]GMAIL.COM
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Abnormal Menstrual Cycle
• Menstruation Disturbances

Intervention

Drug:
• Vaginal tablet Endometrin twice a day
Endometrin 100 mg twice a day

Locations

Country	Name	City	State
Israel	Wolfson medical center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	We would like to investigate whether there is need for luteal support in NC-FET cycle.	4 weeks	No