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Status unknownNCT03486626Updated Jun 26, 2018

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

A Phase 4 interventional study of Metformin in Polycystic Ovary Syndrome and Anovulatory, sponsored by Ain Shams Maternity Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-06-26.

Sponsored by Ain Shams Maternity Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Polycystic Ovary Syndrome
  • Anovulatory
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's enrollment of 85 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Patients

    Drug: Metformin

Interventions

  • Metformin to increase pregnancy rate in polycystic ovarian syndrome patients

06

What researchers measure

Primary outcomes

  1. pregnancy

    polycystic ovarian syndrome patients getting pregnant on receiving Metformin

    Time frame: 4 months

Secondary outcomes

  1. Endometrial thickness and Sub Endometrial vascularity

    Endometrial thickness and Sub Endometrial vascularity before and after receiving Metformin as markers of endometrial receptivity

    Time frame: 4 months

07

Study locations

1 site
  • Ain Shams University Maternity Hospital
    Cairo, 1156, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03486626
Responsible party
Mohamed Adel mohamed kamal Eldin Abdelrahman (Resident of Obstetrics and gynecology, Ain Shams Maternity Hospital) — Principal investigator
First posted
Apr 3, 2018
Start date
Jan 2, 2018
Primary completion
Sep 2018 (estimated)
Completion
Oct 2018 (estimated)
Last update
Jun 26, 2018

Study contacts

Waleed Khalaf, M.D
principal investigator · Ain Shams University Maternity Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Metformin

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