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OpenTrials
Completed

NCT Number: NCT02628756

Endometrial Injury in Women With Unexplained Infertility

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endometrial injury

Procedure

Office hysteroscopy (Karl Storz, Tuttlingen, Germany)

Primary outcomes

  1. Clinical pregnancy rates (PR)

    Time frame: Three consecutive months

Secondary outcomes

  1. Miscarriage rates

    Time frame: Three consecutive months

Sponsors and collaborators

Lead sponsor

Mansoura Integrated Fertility Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2015
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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