Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Poor Responders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158689
• Other study ID #: 10017
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: January 7, 2016
• Start date: June 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Poor Responders

Intervention

Drug:
• Letrozole

• human menopausal gonadotropin (hMG)

Locations

Country	Name	City	State
Turkey	Department of Obstetrics and Gynecology, Istanbul University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Ercan Bastu

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	The primary outcome measure will be the ongoing pregnancy rate (>12 weeks' gestation) per started cycle.	up to 2 weeks	No
Secondary	Cancellation Rate	One of the secondary outcome measures will be cancellation rate.	up to one month	No
Secondary	Number of oocytes retrieved	One of the secondary outcome measures will be number of oocytes retrieved.	up to one month	No
Secondary	Number of transferable embryos	One of the secondary outcome measures will be number of transferable embryos.	up to one month	No
Secondary	Implantation rate	One of the secondary outcome measures will be implantation rates.	up to 2 weeks	No
Secondary	Clinical pregnancy rate	One of the secondary outcome measures will be clinical pregnancy rates.	up to 2 weeks	No