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

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Flare up; Drug: Microdose GnRh

• Registration Number: NCT01006954
• Lead Sponsor: Royan Institute

Brief 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.

Study Timeline

• Study Start: 2008-09
• Status Verified: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-02
• Study First Posted: 2009-11-03
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Last Update Submitted: 2018-12-15
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Poor responders (Presence of at least two of following items is necessary for inclusion to the study)

• History of Cycle Cancellation
• History of oocyte number 3 (in previous cycle)
• History of Number of antral follicle < 5 in previous cycle
• Age≥38
• FSH>12 on day 2 or 3
• Ovarian Volume 3 cm3

Exclusion Criteria

• Male factor (azospermi)
• Myoma ≥6cm
• One way ovary
• Tumor or cyst >13mm
• Age >42

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flare Up	Flare up	Flare up protocol in poor responders for IVF/ICSI
Microdose GnRh	Microdose GnRh	Microflare protocol in poor responders for IVF/ICSI

Primary Outcome Measures

Name	Time	Method
Live birth rate	12 months

Secondary Outcome Measures

Name	Time	Method
Cycle cancellation rates	12 Months
Number of oocytes generated	12 Months
Number of embryos generated	12 Months
Implantation rate	12 Months
Pregnancy rate	12 months

Trial Locations

Locations (1)

1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR; 🇮🇷 Tehran, Iran, Islamic Republic of