Long Protocol and Growth Hormone in Poor Responders

Study Overview
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Brief Summary
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The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.

Official Title
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Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial

Conditions
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Infertility

Intervention / Treatment
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* Drug: Growth hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Poor responder females are those who posses two out of these three criteria: Female age ≥40 years Females who have at least one previous cancelled IVF cycle POR according to AFC ≤ 5 or low AMH value. Exclusion Criteria: Females over 45 years Females with FSH more than 20 IU/l Females with previous ovarian surgery Females suffering from causes of infertility other than poor ovarian response Females refusing to be enrolled in the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Long + Growth hormone<br>Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration. | Drug: Growth hormone<br> <br> * Other names: Norditropin, Novo nordisk;|
| No Intervention: Long protocol only<br>Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | Fresh, Frozen, Cumulative | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility