Back to resultsImpact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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)
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metformin-treated group
Placebo
Arm Description
51 overweight and obese women (BMI>24) with PCOS underwent their first fresh autologous IVF-embryo transfer cycle
A cohort of fifty-one cross matched PCOS women
Outcomes
Primary Outcome Measures
Total number of retrieved oocytes
Secondary Outcome Measures
Live birth rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02910817
Brief Title
Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women
Official Title
Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese Polycystic Ovary Syndrome Women; A Quasi Experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with PCOS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin-treated group
Arm Type
Experimental
Arm Description
51 overweight and obese women (BMI>24) with PCOS underwent their first fresh autologous IVF-embryo transfer cycle
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A cohort of fifty-one cross matched PCOS women
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Total number of retrieved oocytes
Time Frame
Two weeks Metformin treatment
Secondary Outcome Measure Information:
Title
Live birth rate
Time Frame
End of the pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Abdalmageed
Organizational Affiliation
Women health center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29576001
Citation
Abdalmageed OS, Farghaly TA, Abdelaleem AA, Abdelmagied AE, Ali MK, Abbas AM. Impact of Metformin on IVF Outcomes in Overweight and Obese Women With Polycystic Ovary Syndrome: A Randomized Double-Blind Controlled Trial. Reprod Sci. 2019 Oct;26(10):1336-1342. doi: 10.1177/1933719118765985. Epub 2018 Mar 25.
Results Reference
derived
Learn more about this trial
Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women
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