NCT02910817

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

September 9, 2016

Last Update Submit

November 12, 2017

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Total number of retrieved oocytes

    Two weeks Metformin treatment

Secondary Outcomes (1)

  • Live birth rate

    End of the pregnancy

Study Arms (2)

Metformin-treated group

EXPERIMENTAL

51 overweight and obese women (BMI\>24) with PCOS underwent their first fresh autologous IVF-embryo transfer cycle

Drug: Metformin

Placebo

PLACEBO COMPARATOR

A cohort of fifty-one cross matched PCOS women

Other: Placebo

Interventions

MetforminDRUG

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.

Metformin-treated group
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 29576001DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Osama Abdalmageed

    Women health center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of OBGYN in women health hospital

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 22, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)