Antagonist Protocol in Poor Responders

Study Overview
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Brief Summary
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The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.

Detailed Description
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Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.

Official Title
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Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial

Conditions
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Female Infertility Due to Diminished Ovarian Reserve

Intervention / Treatment
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* Drug: Growth Hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: females fulfilling the criteria of the ESHRE consensus 2011: at least two of the following three features must be present: dvanced maternal age (≥40 years) or any other risk factor for POR previous POR (≤3 oocytes with a conventional stimulation protocol) an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml). Exclusion Criteria: women who suffer from any other cause of infertility other than poor ovarian reserve refusal of the patient to consent for using her data in the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antagonist and Growth hormone<br>HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. | Drug: Growth Hormone<br>* Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.<br>* Other names: Norditropin, Novo nordisk;|
| No Intervention: Antagonist<br>HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | Up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | Up to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth hormone, IVF/ICSI, Poor responder, Antagonist protocol