Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

Infertility Clinical Trial

Official title:

Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419353
• Other study ID #: Antagonist_prog
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2011
• Last updated: December 23, 2013
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2011
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if pretreatment with Estrogen can assist in the planning and programming of In Vitro Fertilization treatments.

Description:

A randomised controlled trial in which study group will be given estrogen derivative before ovarian stimulation in GnRH antagonist protocol and compared to the classical GnRH agonist protocol.Estrogen will be given P.O , "PROGYNOVA' , in a dose of 2 mg /d, starting day 2 of menses and until first Monday to follow. Main outcome measure will be ability to control the ovum pickup day, calculated as a rate of ideal pickups divided by the entire pickup number. All women enrolled will be under 38 years of age, with a clear indication for IVF other than ovulatory dysfunction. women with past 4 treatment failures will be excluded as well as cases in which sperm achieved in surgical methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 38 Years

Eligibility

Inclusion Criteria:

• IVF treatment in the following indications: Male, Mechanical, Unexplained

• Age<38 years

• Treatment Cycle number 1-4

Exclusion Criteria:

• Ovulatory disorder as an indication for IVF

• Repeated failure in previous IVF treatments (> than 4 cycles)

• Sperm used for treatment was retrieved by surgical procedure

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• estradiol valerate
2 mg P.O / day for 1-6 days.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovum pickup rate that took place between Sunday to Thursday without a compromise	number of Pickups that took place between Sunday to Thursday (without a compromise in treatment) \ by the entire pickup number	a year	No
Secondary	pregnancy rate	comparison of pregnancy rate between the 2 groups. calculated per cycle	a year	No