Outcome of Three Controlled Ovarian Hyperstimulation Protocols in Poor Responding Infertility Patients

Study Overview
=================
Brief Summary
-----------------
There are different controlled ovarian hyperstimulation protocols utilized in infertility patients. In this study, our aim is to specifically compare three protocols in poor responding infertility patients.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: FSH 225IU and hMG 225IU
* Drug: FSH 150IU and hMG 150IU
* Drug: Letrozole 5mg and hMG 150IU


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Combined 450<br>Recombinant FSH 225IU/day and human menopausal gonadotropin (hMG) 225IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. | Drug: FSH 225IU and hMG 225IU<br> <br> |
| Active Comparator: Combined 300<br>Recombinant FSH 150IU/day and human menopausal gonadotropin (hMG) 150IU/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 10000IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. | Drug: FSH 150IU and hMG 150IU<br> <br> |
| Active Comparator: Letrozole and hMG<br>Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day and human menopausal gonadotropin (hMG) 150IU/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: Letrozole 5mg and hMG 150IU<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | 4 weeks | 
| Number of transferable embryos |  | 4 weeks | 
| Biochemical pregnancy rate |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
poor responders