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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Microdose GnRh
Flare up
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Poor responder, Flare up, Micro dose GnRH agonist flare up, IVF/ICSI

Eligibility Criteria

30 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • 1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Flare Up

Microdose GnRh

Arm Description

Flare up protocol in poor responders for IVF/ICSI

Microflare protocol in poor responders for IVF/ICSI

Outcomes

Primary Outcome Measures

Live birth rate

Secondary Outcome Measures

Cycle cancellation rates
Number of oocytes generated
Number of embryos generated
Implantation rate
Pregnancy rate

Full Information

First Posted
November 2, 2009
Last Updated
December 15, 2018
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01006954
Brief Title
Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Poor responder, Flare up, Micro dose GnRH agonist flare up, IVF/ICSI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flare Up
Arm Type
Active Comparator
Arm Description
Flare up protocol in poor responders for IVF/ICSI
Arm Title
Microdose GnRh
Arm Type
Experimental
Arm Description
Microflare protocol in poor responders for IVF/ICSI
Intervention Type
Drug
Intervention Name(s)
Microdose GnRh
Other Intervention Name(s)
Case
Intervention Description
Microflare protocol in poor responders for IVF/ICSI
Intervention Type
Drug
Intervention Name(s)
Flare up
Other Intervention Name(s)
Standard treatment
Intervention Description
Flare up protocol in poor responders for IVF/ICSI
Primary Outcome Measure Information:
Title
Live birth rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cycle cancellation rates
Time Frame
12 Months
Title
Number of oocytes generated
Time Frame
12 Months
Title
Number of embryos generated
Time Frame
12 Months
Title
Implantation rate
Time Frame
12 Months
Title
Pregnancy rate
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahereh Madani, MD
Organizational Affiliation
Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Firoozeh Ghaffari, MD
Organizational Affiliation
Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tahereh Madani, MD
Organizational Affiliation
Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31569274
Citation
Ghaffari F, Jahangiri N, Madani T, Khodabakhshi S, Chehrazi M. Randomized controlled trial of gonadotropin-releasing hormone agonist microdose flare-up versus flare-up among poor responders undergoing intracytoplasmic sperm injection. Int J Gynaecol Obstet. 2020 Jan;148(1):59-64. doi: 10.1002/ijgo.12988. Epub 2019 Oct 18.
Results Reference
derived
Links:
URL
http://WWW.Royaninstitute.org
Description
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Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle

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