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

NCT ID: NCT02910817

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Metformin-treated group

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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.

Placebo

A cohort of fifty-one cross matched PCOS women

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Osama Saber Thabet Abdalmageed

Lecturer of OBGYN in women health hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Abdalmageed

Role: PRINCIPAL_INVESTIGATOR

Women health center

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 29576001 (View on PubMed)

Other Identifiers

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obgy-115-2014

Identifier Type: -

Identifier Source: org_study_id