Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Study Overview
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Brief Summary
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The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.

Conditions
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Poor Responders

Intervention / Treatment
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* Drug: Letrozole
* Drug: human menopausal gonadotropin (hMG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011). Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder: advanced maternal age (≥40 years) or any other risk factor for poor ovarian response; a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or an abnormal ovarian reserve test (antral follicle count, <7 follicles or anti-Mullerian hormone, <1.1 ng/ml).

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: human menopausal gonadotropin (hMG)<br>hMG at a dose of 300 IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. | Drug: human menopausal gonadotropin (hMG)<br> <br> |
| Active Comparator: Letrozole<br>Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day will be initiated on the second or third day of spontaneous menstruation and continued for 5 days. Again on the second or third day of spontaneous menstruation, 150 IU of hMG will be started until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of hCG as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. | Drug: Letrozole<br> <br> * Other names: Femara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | The primary outcome measure will be the ongoing pregnancy rate (>12 weeks' gestation) per started cycle. | up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancellation Rate | One of the secondary outcome measures will be cancellation rate. | up to one month | 
| Number of oocytes retrieved | One of the secondary outcome measures will be number of oocytes retrieved. | up to one month | 
| Number of transferable embryos | One of the secondary outcome measures will be number of transferable embryos. | up to one month | 
| Implantation rate | One of the secondary outcome measures will be implantation rates. | up to 2 weeks | 
| Clinical pregnancy rate | One of the secondary outcome measures will be clinical pregnancy rates. | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Poor responders, letrozole, human menopausal gonadotropin