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

Istanbul University

Status: Completed

Conditions: Infertility

Treatments: Drug: FSH 225IU and hMG 225IU; Drug: FSH 150IU and hMG 150IU; Drug: Letrozole 5mg and hMG 150IU

Study type: Interventional

Funder types: Other

Identifiers

NCT02293668

1001

Details and patient eligibility

About

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.

Enrollment: 95 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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95 participants in 3 patient groups

Combined 450

Active Comparator group

Description:

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.

Treatment:

Drug: FSH 225IU and hMG 225IU

Combined 300

Active Comparator group

Description:

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.

Treatment:

Drug: FSH 150IU and hMG 150IU

Letrozole and hMG

Active Comparator group

Description:

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.

Treatment:

Drug: Letrozole 5mg and hMG 150IU