Endometrial Injury in Women With Unexplained Infertility

Status Completed

Clinical Trial 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.

Clinical Trial 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02628756
Study type	Interventional
Source	Mansoura Integrated Fertility Center
Contact
Status	Completed
Phase	N/A
Start date	June 2013
Completion date	July 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04169451` - IUI With Letrozole Versus in Natural Cycle	N/A
Completed	`NCT01672801` - Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT	N/A
Completed	`NCT01232465` - Impact of Sperm DNA Integrity on In Vitro Cycles	N/A
Not yet recruiting	`NCT01237535` - Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates	Phase 4
Completed	`NCT02272439` - Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan	N/A
Terminated	`NCT00650754` - Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility	Phase 2/Phase 3
Recruiting	`NCT04754243` - New Protocol in Unexplained Infertility	Phase 4
Completed	`NCT03018314` - Serum Kisspeptin Levels in Infertile Women	N/A
Completed	`NCT02488434` - The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility	Phase 3
Completed	`NCT02739516` - Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility	Phase 3
Completed	`NCT01044862` - Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation	Phase 3
Recruiting	`NCT03386552` - A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility	Phase 2
Completed	`NCT04465045` - Unexplained Infertility Treated by Hysteroscopy-laparoscopy
Completed	`NCT03461601` - Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility	N/A
Completed	`NCT01859520` - Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa	N/A
Active, not recruiting	`NCT03828786` - Uterine Scratching in Intra-Uterine Insemination	N/A
Completed	`NCT03397693` - Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.
Withdrawn	`NCT04955574` - Probiotic and Antibiotic Therapies in Women With Unexplained Infertility	Phase 2
Not yet recruiting	`NCT03398993` - Effect of Endometrial Injury in Couples With Unexplained Infertility	N/A
Completed	`NCT02861105` - The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.