NCT03398993

Brief Summary

100 patient of unexplained infertility recruited and divided into two groups for the study group (50) endometrial scratching done in preovulatory period after controlled ovarian stimulation by clomiphene citrate , then followed and compared to control group for 6 months to asses pregnancy rate

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

January 8, 2018

Last Update Submit

January 8, 2018

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    intrauterine gestational sac

    4 weeks after missed period

Study Arms (2)

Scratch group

ACTIVE COMPARATOR

Induction of ovulation will be done by clomophine citrate from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18\_20mm in size. Then endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) The procedure was carried out in preovulatory day (known when dominant follicle reached 18\_20 mm in diameter), usually, done around day 14-day of the cycle

Drug: Clomiphene CitrateDrug: Human chorionic gonadotropinDevice: Endometrial scratch

Non scratch group

ACTIVE COMPARATOR

They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day

Drug: Clomiphene CitrateDrug: Human chorionic gonadotropin

Interventions

Clomiphene CitrateDRUG

50 mg twice daily from3rd day of cycle till 7th day of cycle

Also known as: clomid
Non scratch groupScratch group
Human chorionic gonadotropinDRUG

75 IU dail;y from 6th day of cycle till 8th of cycle once daily

Also known as: MerionaL
Non scratch groupScratch group
Endometrial scratchDEVICE

The procedure was carried out in preovulatory day (known when dominant follicle reached 18\_20 mm in diameter), usually, done around day 14-day of the cycle. In the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix. Cervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus. The procedure took approximately 15minutes to complete

Scratch group

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unexplained infertility ( 1ry \& 2ndry infertility) : \*
  • Normal hormonal profile of infertile woman.
  • Normal hystrosalpingogram.
  • Normal laparoscopy.
  • Normal investigation of the cervical factor
  • Fertile semen analysis (according to world health organization criteria 2015).

You may not qualify if:

  • Infertile semen analysis.
  • Abnormal HSG.
  • Abnormal laparoscopic findings.
  • Disturbed hormonal profile.
  • Evidence of cervical factor.
  • Known genetic disorder
  • Known autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

ClomipheneChorionic GonadotropinhMG-IBSA

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Ahmed Maged

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed maged

CONTACT

+20201005227404dr_ahmedmaged08@kasralainy.edu.eg

ameer elsherief

CONTACT

ameerelsherief@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

EG(1)