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

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293668
• Other study ID #: 1001
• Status: Completed
• Phase: N/A
• First received: November 14, 2014
• Last updated: January 7, 2016
• Start date: November 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: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• 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, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• FSH 225IU and hMG 225IU

• FSH 150IU and hMG 150IU

• Letrozole 5mg and hMG 150IU

Locations

Country	Name	City	State
Turkey	Istanbul University School of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

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	Clinical pregnancy rate		8 weeks	No
Secondary	Number of oocytes retrieved		4 weeks	No
Secondary	Number of transferable embryos		4 weeks	No
Secondary	Biochemical pregnancy rate		6 weeks	No