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

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ClinicalTrials.gov Identifier: NCT01006954
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Microdose GnRh Drug: Flare up Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2008
Primary Completion Date : January 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Cycle cancellation rates [ Time Frame: 12 Months ]
  2. Number of oocytes generated [ Time Frame: 12 Months ]
  3. Number of embryos generated [ Time Frame: 12 Months ]
  4. Implantation rate [ Time Frame: 12 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 42 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01006954     History of Changes
Other Study ID Numbers: Royan-Emb-003
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: November 2009

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