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

December 15, 2018 updated by: Royan Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 14114
        • 1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flare Up
Flare up protocol in poor responders for IVF/ICSI
Drug: Flare up
Flare up protocol in poor responders for IVF/ICSI
Other Names:
  • Standard treatment
Experimental: Microdose GnRh
Microflare protocol in poor responders for IVF/ICSI
Drug: Microdose GnRh
Microflare protocol in poor responders for IVF/ICSI
Other Names:
  • Case

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: 12 months
12 months
Cycle cancellation rates
Time Frame: 12 Months
12 Months
Number of oocytes generated
Time Frame: 12 Months
12 Months
Number of embryos generated
Time Frame: 12 Months
12 Months
Implantation rate
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • Study Chair: Tahereh Madani, MD, Royan Institute
  • Study Director: Firoozeh Ghaffari, MD, Royan Institute
  • Principal Investigator: Tahereh Madani, MD, Royan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

November 2, 2009

First Submitted That Met QC Criteria

November 2, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 15, 2018

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Emb-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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