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Endometrial Injury in Women With Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT02628756
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Tarek Shokeir, Mansoura Integrated Fertility Center

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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 : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. Clinical pregnancy rates (PR) [ Time Frame: Three consecutive months ]

Secondary Outcome Measures :
  1. Miscarriage rates [ Time Frame: Three consecutive months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Uterine fibroid.
  2. Pelvic endometriosis.
  3. Irregular menstruation.
  4. Ovarian cysts.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628756


Sponsors and Collaborators
Mansoura Integrated Fertility Center
Investigators
Principal Investigator: Tarek Shokeir, M.D. Mansoura University Hospital, Mansoura Faculty of Medicine

Responsible Party: Tarek Shokeir, Prof. Obstetrics & Gynecology, Mansoura Integrated Fertility Center
ClinicalTrials.gov Identifier: NCT02628756     History of Changes
Other Study ID Numbers: MS/490
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female