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

Sponsor

Ain Shams Maternity Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03486626

Collaborator

(none)

Enrollment

Location

Arm

8.9

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Anovulatory	Drug: Metformin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2018

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Patients

Drug: Metformin

Metformin to increase pregnancy rate in polycystic ovarian syndrome patients

Outcome Measures

Primary Outcome Measures

pregnancy [4 months]
polycystic ovarian syndrome patients getting pregnant on receiving Metformin

Secondary Outcome Measures

Endometrial thickness and Sub Endometrial vascularity [4 months]
Endometrial thickness and Sub Endometrial vascularity before and after receiving Metformin as markers of endometrial receptivity

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity Hospital	Cairo		Egypt	1156

Sponsors and Collaborators

Ain Shams Maternity Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Adel mohamed kamal Eldin Abdelrahman, Resident of Obstetrics and gynecology, Ain Shams Maternity Hospital

ClinicalTrials.gov Identifier:

NCT03486626

Other Study ID Numbers:

Ain ShamsMH

First Posted:

Apr 3, 2018

Last Update Posted:

Jun 26, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Anovulation

Syndrome

Metformin

Study Results

No Results Posted as of Jun 26, 2018