Microflare Protocol in Poor Responders

Study Overview
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Brief Summary
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The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders

Detailed Description
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The microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

Official Title
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Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?

Conditions
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Female Infertility Due to Diminished Ovarian Reserve

Intervention / Treatment
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* Drug: Growth hormone (Norditropin, Novo nordisk)


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: (i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) 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: Microflare and growth hormone<br>the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. 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 (Norditropin, Novo nordisk)<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: Microflare protocol alone<br>the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rates |  | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth hormone, Poor responders, Poor ovarian response, IVF/ICSI, Microflare protocol, Oral contraceptive pills