Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Ercan Bastu

Status: Completed

Conditions: Poor Responders

Treatments: Drug: Letrozole; Drug: human menopausal gonadotropin (hMG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02158689

10017

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

human menopausal gonadotropin (hMG)

Active Comparator group

Description:

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.

Treatment:

Drug: human menopausal gonadotropin (hMG)

Letrozole

Active Comparator group

Description:

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.

Treatment:

Drug: Letrozole