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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle

Conditions
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Infertility

Intervention / Treatment
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* Drug: Microdose GnRh
* Drug: Flare up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flare Up<br>Flare up protocol in poor responders for IVF/ICSI | Drug: Flare up<br>* Flare up protocol in poor responders for IVF/ICSI<br>* Other names: Standard treatment;|
| Experimental: Microdose GnRh<br>Microflare protocol in poor responders for IVF/ICSI | Drug: Microdose GnRh<br>* Microflare protocol in poor responders for IVF/ICSI<br>* Other names: Case;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poor responder, Flare up, Micro dose GnRH agonist flare up, IVF/ICSI