Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

Study Overview
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Brief Summary
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During assisted reproduction technology treatments like in vitro fertilization, some patients give a poor ovarian response to controlled ovarian hyperstimulation. The European Society of Human Reproduction and Embryology consensus defined poor response to ovarian stimulation during in vitro fertilization with Bologna criteria. Bologna criteria: At least two of the following three features must be present: (i) Advanced maternal age (≥40 years). (ii) Previous Poor responders (≤3 oocytes with a conventional stimulation protocol). (iii) An abnormal ovarian reserve test Most controlled ovarian hyperstimulation regimens currently used for expected poor responders are based on using a high daily dose (300- 450 IU/day) of exogenous gonadotropins. Giving a high gonadotropin dose obviously increases the cost of in vitro fertilization, a consequence that would be acceptable if paralleled by an improvement in in vitro fertilization outcome. Unfortunately, however, the available data suggest that increasing the daily gonadotropins dose may increase the number of retrieved oocytes, but not the final success rate of in vitro fertilization.

Official Title
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Soft Versus Conventional Protocol in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles for Poor Responders

Conditions
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ART

Intervention / Treatment
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* Drug: Letrozole
* Drug: Menotropins
* Drug: recombinant Follicular stimulating hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced maternal age (≥40 years) . Previous Poor responders (≤3 oocytes with a conventional stimulation protocol). An abnormal ovarian reserve tests Exclusion Criteria: Hyper or Normal responders patients. Endocrine or metabolic diseases like hyperprolactinoma, hypothyroidism,...etc Patients with a severe male factor abnormality. 4-Patients with systemic disease such as chronic renal disease, chronic liver disease, etc

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Other: Soft ovarian stimulation protocol<br> | Drug: Letrozole<br>* Oral tablet letrozole 2,5 mg/twice daily for 5 days<br>Drug: Menotropins<br>* 150 IU of highly purified menotropins intramuscular<br>|
| Other: conventional ovarian stimulation protocol<br> | Drug: Menotropins<br>* 150 IU of highly purified menotropins intramuscular<br>Drug: recombinant Follicular stimulating hormone<br>* recombinant Follicular stimulating hormone 300- 400 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total gonadotrophins dose |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ovarian stimulation |  | 14 days | 
| Endometrial thickness | by ultrasounds | 14 days |