NCT03681197

Brief Summary

The aim of this study is to asses the effect of metformin on clinical pregnancy rate in women with unexplained infertility (randomized controlled trial). This study will be conducted in infertility clinic,Ain Shams university maternity hospital,170 women with unexplained infertility will be enrolled in this study. Statistical analysis of the data will be performed .

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
170

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2018

Shorter than P25 for early_phase_1

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

June 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

August 13, 2018

Last Update Submit

March 20, 2019

Conditions

Infertility

Keywords

metformin,unexplained infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Diagnosis of pregnancy by transvaginal ulterasound

    one cycle for each woman (28 days in average)

Study Arms (2)

Metformin Group

ACTIVE COMPARATOR

Will receive metformin plus clomiphene citrate

Drug: MetforminDrug: Clomiphene Citrate

Placebo

PLACEBO COMPARATOR

Will receive placebo plus clomiphene citrate.

Drug: PlaceboDrug: Clomiphene Citrate

Interventions

MetforminDRUG

Metformin 850 mg tablet will be started twice daily immediately at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.

Also known as: glucophage
Metformin Group
PlaceboDRUG

In placebo group,placebo will be strted twice daily at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.

Placebo
Clomiphene CitrateDRUG

50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days

Also known as: Clomid
Metformin GroupPlacebo

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-35 years old.
  • BMI 20-\<30
  • FSH 12 IU/L or less
  • Normal transvaginal ulterasound(normal uterus and ovaries with no congenital anomalies).
  • Patent fallopian tubes assesd by hysterosalpingogram or laparoscopy.
  • Normal semen analysis.
  • Infertile women with history of previous failed induction cycle.

You may not qualify if:

  • Women younger than 20 or elder than 35 years old.
  • Women with BMI equal to or more than 30.
  • Uncorrected congenital or acquired uterine anomaly.
  • Other causes of infertility rather than unexplained infertility.
  • Patient with Diabetes Mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elham Raafat Mohamed

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

MetforminClomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Sarah S Moawad, Lecturer

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

  • Ahmed M Bahaa Eldin, Professor

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

  • Hisham M Fathy, Professor

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

Central Study Contacts

Elham R Mohamed

CONTACT

0021156230921Elhamraafat@outlook.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Each of the consecutive women numbers will be written on sequentially numbered opaque sealed envelope that contains the assignment code.At the time of procedure,the responsible investigator will open the envelope to reveal the assignment,and she will introduce the planned method. Monitoring and follow up will be done. After enrollment,the cases will be randomly allocated into two groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident of obstetric and gynecology

Study Record Dates

First Submitted

August 13, 2018

First Posted

September 21, 2018

Study Start

June 15, 2018

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)