Endometrial Thickness and Subendometrial Vascularity in Anovulatory Polycystic Ovarian Syndrome Patients Treated by Metformin

Endometrial Thickness And Subendometrial Vascularity In Anovulatory Polycystic Ovarian Syndrome Patients Treated by Metformin

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.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome; Anovulatory
• Intervention / Treatment: Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1156
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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:

Hyperandrogenism: Hirsutism and/or Hyperandrogenaemia Ovarian Dysfunction : Oligo-Anovulation and /or Polycystic ovaries Exclusion of other Androgen Excess or related disorders as :( deficient nonclassic adrenal hyperplasia, androgen-secreting neoplasms, androgenic/anabolic drug use or abuse, Cushing's syndrome, the Hyperandrogenic-Insulin Resistance-Acanthosis Nigricans syndrome, thyroid dysfunction, and hyperprolactinemia).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients	Drug: Metformin; Metformin to increase pregnancy rate in polycystic ovarian syndrome patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy	polycystic ovarian syndrome patients getting pregnant on receiving Metformin	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness and Sub Endometrial vascularity	Endometrial thickness and Sub Endometrial vascularity before and after receiving Metformin as markers of endometrial receptivity	4 months

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Principal Investigator: Waleed Khalaf, M.D, Ain Shams University Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: April 1, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Anovulation; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: Ain ShamsMH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes