NCT03486626

Brief Summary

The participants will receive metformin 500mg 3times per day for 3months and one month is left for spontaneous pregnancy to occur or not (primary outcome ) and the investigators will check endometrial thickness and subendometerial vascularity as markers of endometrial receptivity before and after the treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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 2, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

March 25, 2018

Last Update Submit

June 25, 2018

Conditions

Polycystic Ovary SyndromeAnovulatory

Outcome Measures

Primary Outcomes (1)

  • pregnancy

    polycystic ovarian syndrome patients getting pregnant on receiving Metformin

    4 months

Secondary Outcomes (1)

  • Endometrial thickness and Sub Endometrial vascularity

    4 months

Study Arms (1)

Patients

EXPERIMENTAL
Drug: Metformin

Interventions

MetforminDRUG

Metformin to increase pregnancy rate in polycystic ovarian syndrome patients

Patients

Eligibility Criteria

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

You may qualify if:

  • PCO syndrome patients have the following criteria:
  • Age of the patient between 20 - 40 years old. All subjects are not on a specific diet nor a certain program of physical exercise Complaining of infertility either primary or secondary due to PCOS.
  • N.B: The diagnosis of PCO syndrome was made according to the Androgen Excess and Polycystic Ovarian Syndrome Society: the presence of the following criteria have been required for the diagnosis of PCO syndrome:

You may not qualify if:

  • Age below 20 or above 40. Women who intended to start a diet or a specific program of physical activity. Concurrent medical illness as cardiovascular, neoplastic and hepatic disorder. Pelvic pathology. Tubal, Uterine, Male factor of infertility. Endocrinological factors including: diabetes Mellitus,hypothyroidism, hyperprolactinaemia, Cushing's syndrome, and non- classical congenital adrenal hyperplasia.
  • Patients who are ovulatory during the ovarian cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 1156, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulation

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

  • Waleed Khalaf, M.D

    Ain Shams University Maternity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Obstetrics and gynecology

Study Record Dates

First Submitted

March 25, 2018

First Posted

April 3, 2018

Study Start

January 2, 2018

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

EG(1)