Skip to content

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01006954
Enrollment
200
Registered
2009-11-03
Start date
2008-09-30
Completion date
2010-02-28
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Poor responder, Flare up, Micro dose GnRH agonist flare up, IVF/ICSI

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.

Interventions

DRUGMicrodose GnRh

Microflare protocol in poor responders for IVF/ICSI

DRUGFlare up

Flare up protocol in poor responders for IVF/ICSI

Sponsors

Royan Institute
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 42 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Live birth rate12 months

Secondary

MeasureTime frame
Cycle cancellation rates12 Months
Number of oocytes generated12 Months
Number of embryos generated12 Months
Implantation rate12 Months
Pregnancy rate12 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026