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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01006954
First received: November 2, 2009
Last updated: May 7, 2014
Last verified: November 2009

November 2, 2009
May 7, 2014
September 2008
January 2010   (final data collection date for primary outcome measure)
Pregnancy rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01006954 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Infertility
  • Drug: Microdose GnRh
    Microflare protocol in poor responders for IVF/ICSI
    Other Name: Case
  • Drug: Flare up
    Flare up protocol in poor responders for IVF/ICSI
    Other Name: Standard treatment
  • Active Comparator: Flare Up
    Flare up protocol in poor responders for IVF/ICSI
    Intervention: Drug: Flare up
  • Experimental: Microdose GnRh
    Microflare protocol in poor responders for IVF/ICSI
    Intervention: Drug: Microdose GnRh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
30 Years to 42 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01006954
Royan-Emb-003
Yes
Royan Institute
Royan Institute
Not Provided
Study Chair: Tahereh Madani, MD Royan Institute
Study Director: Firoozeh Ghaffari, MD Royan Institute
Principal Investigator: Tahereh Madani, MD Royan Institute
Royan Institute
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP