Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Not Applicable

Completed

• Conditions: Poor Responders
• Interventions: Drug: human menopausal gonadotropin (hMG); Drug: Letrozole

• Registration Number: NCT02158689
• Lead Sponsor: Ercan Bastu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-27
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-06
• Study First Posted: 2014-06-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
human menopausal gonadotropin (hMG)	human menopausal gonadotropin (hMG)	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.
Letrozole	Letrozole	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.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	up to 2 weeks	The primary outcome measure will be the ongoing pregnancy rate (\>12 weeks' gestation) per started cycle.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Istanbul University School of Medicine; 🇹🇷 Istanbul, Turkey