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

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT01006954
First received: November 2, 2009
Last updated: July 14, 2011
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Drug: Microdose GnRh
Drug: Flare up
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cycle cancellation rates [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Number of oocytes generated [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Number of embryos generated [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Case

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.

  Eligibility

Ages Eligible for Study:   30 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006954

Locations
Iran, Islamic Republic of
1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Tahereh Madani, MD Royan Institute
Study Director: Firoozeh Ghaffari, MD Royan Institute
Principal Investigator: Tahereh Madani, MD Royan Institute
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hamid Gourabi, Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT01006954     History of Changes
Other Study ID Numbers: Royan-Emb-003
Study First Received: November 2, 2009
Last Updated: July 14, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Poor responder
Flare up
Micro dose GnRH agonist flare up
IVF/ICSI

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013