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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedDecember 19, 2018
November 1, 2009
1.3 years
November 2, 2009
December 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate
12 months
Secondary Outcomes (5)
Cycle cancellation rates
12 Months
Number of oocytes generated
12 Months
Number of embryos generated
12 Months
Implantation rate
12 Months
Pregnancy rate
12 months
Study Arms (2)
Flare Up
ACTIVE COMPARATORFlare up protocol in poor responders for IVF/ICSI
Microdose GnRh
EXPERIMENTALMicroflare protocol in poor responders for IVF/ICSI
Interventions
Microflare protocol in poor responders for IVF/ICSI
Flare up protocol in poor responders for IVF/ICSI
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Male factor (azospermi)
- Myoma ≥6cm
- One way ovary
- Tumor or cyst \>13mm
- Age \>42
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR
Tehran, 14114, Iran
Related Publications (1)
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.
PMID: 31569274DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tahereh Madani, MD
Royan Institute
- STUDY DIRECTOR
Firoozeh Ghaffari, MD
Royan Institute
- PRINCIPAL INVESTIGATOR
Tahereh Madani, MD
Royan Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 3, 2009
Study Start
September 1, 2008
Primary Completion
January 1, 2010
Study Completion
February 1, 2010
Last Updated
December 19, 2018
Record last verified: 2009-11