NCT02628756

Brief Summary

Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Status
completed

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 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

2.1 years

First QC Date

December 8, 2015

Last Update Submit

December 10, 2015

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rates (PR)

    Three consecutive months

Secondary Outcomes (1)

  • Miscarriage rates

    Three consecutive months

Study Arms (1)

Endometrial injury

EXPERIMENTAL

Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany).

Procedure: Endometrial injury

Interventions

Endometrial injuryPROCEDURE

Office hysteroscopy (Karl Storz, Tuttlingen, Germany)

Endometrial injury

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 39 years old.
  • Normal HSG and/or diagnostic laparoscopy.
  • Normal seminal profile.
  • Regular ovulation confirmed by mid-luteal progesterone.
  • Normal TVS criteria.

You may not qualify if:

  • Uterine fibroid.
  • Pelvic endometriosis.
  • Irregular menstruation.
  • Ovarian cysts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Tarek Shokeir, M.D.

    Mansoura University Hospital, Mansoura Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Obstetrics & Gynecology

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 11, 2015

Study Start

June 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 14, 2015

Record last verified: 2015-12