Endometrial Injury in Women With Unexplained Infertility

Sponsor

Mansoura Integrated Fertility Center (Other)

Overall Status

Completed

CT.gov ID

NCT02628756

Collaborator

(none)

120

Enrollment

Arm

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Unexplained Infertility	Procedure: Endometrial injury	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endometrial injury Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany).	Procedure: Endometrial injury Office hysteroscopy (Karl Storz, Tuttlingen, Germany)

Arm

Intervention/Treatment

Experimental: Endometrial injury

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

Procedure: Endometrial injury

Office hysteroscopy (Karl Storz, Tuttlingen, Germany)

Outcome Measures

Primary Outcome Measures

Clinical pregnancy rates (PR) [Three consecutive months]

Secondary Outcome Measures

Miscarriage rates [Three consecutive months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mansoura Integrated Fertility Center

Investigators

Principal Investigator: Tarek Shokeir, M.D., Mansoura University Hospital, Mansoura Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tarek Shokeir, Prof. Obstetrics & Gynecology, Mansoura Integrated Fertility Center

ClinicalTrials.gov Identifier:

NCT02628756

Other Study ID Numbers:

MS/490

First Posted:

Dec 11, 2015

Last Update Posted:

Dec 14, 2015

Last Verified:

Dec 1, 2015

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Dec 14, 2015