NCT01006954

Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle

Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: Female
• Age: 30 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.

Detailed description

In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient. The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up. Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become \>14. 2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Microdose GnRh	Microflare protocol in poor responders for IVF/ICSI
DRUG	Flare up	Flare up protocol in poor responders for IVF/ICSI

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2009-11-03
• Last updated: 2018-12-19

Locations

1 site across 1 country: Iran