Endometrial Injury in Women With Unexplained Infertility
Primary Purpose
Unexplained Infertility
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endometrial injury
Sponsored by
About this trial
This is an interventional treatment trial for Unexplained Infertility
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Uterine fibroid.
- Pelvic endometriosis.
- Irregular menstruation.
- Ovarian cysts.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endometrial injury
Arm Description
Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany).
Outcomes
Primary Outcome Measures
Clinical pregnancy rates (PR)
Secondary Outcome Measures
Miscarriage rates
Full Information
NCT ID
NCT02628756
First Posted
December 8, 2015
Last Updated
December 10, 2015
Sponsor
Mansoura Integrated Fertility Center
1. Study Identification
Unique Protocol Identification Number
NCT02628756
Brief Title
Endometrial Injury in Women With Unexplained Infertility
Official Title
Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura Integrated Fertility Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath.
The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure.
Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial injury
Arm Type
Experimental
Arm Description
Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany).
Intervention Type
Procedure
Intervention Name(s)
Endometrial injury
Intervention Description
Office hysteroscopy (Karl Storz, Tuttlingen, Germany)
Primary Outcome Measure Information:
Title
Clinical pregnancy rates (PR)
Time Frame
Three consecutive months
Secondary Outcome Measure Information:
Title
Miscarriage rates
Time Frame
Three consecutive months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Uterine fibroid.
Pelvic endometriosis.
Irregular menstruation.
Ovarian cysts.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Shokeir, M.D.
Organizational Affiliation
Mansoura University Hospital, Mansoura Faculty of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Endometrial Injury in Women With Unexplained Infertility
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