Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women

Polycystic Ovary Syndrome Clinical Trial

Official title:

Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese Polycystic Ovary Syndrome Women; A Quasi Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910817
• Other study ID #: obgy-115-2014
• Status: Completed
• Phase: N/A
• First received: September 9, 2016
• Last updated: November 12, 2017
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria restricted the patients to 39 years old with basal FSH < 10 IU/ml and normal TSH and prolacin.

Exclusion Criteria:

• Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH =10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)

Related Conditions & MeSH terms

• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin
The metformin-treated group received metformin (1000 mg per day) with the start of controlled ovarian stimulation (COH) until the day of the pregnancy check.

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of retrieved oocytes		Two weeks Metformin treatment
Secondary	Live birth rate		End of the pregnancy