Endometrial Scratching by Pipelle on Pregnancy Rate in Unexplained Infertility

NCT02084914 | Unknown Phase 3 DMC

• 1 other identifier: ESBPOPRIUI
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Research question: Population: women with unexplained infertility. Intervention: endometrial scratching by pipelle for women with unexplained infertility. Comparison: to compare with non endometrial scratching for women with unexplained infertility. Outcome: the biochemical pregnancy rate. Research hypothesis: Null hypothesis: there is no difference in the rate of pregnancy between scratching and non endometrial scratching in women with unexplained infertility. Alternative hypothesis: there is difference in the rate of pregnancy between scratching and non endometrial scratching in women with unexplained infertility.

Conditions

Unexplained Infertility

Keywords

endometrial scratching; pipelle; pregnancy rate; unexplained infertility

Outcome Measures

Primary Outcomes (1)

• Biochemical Pregnancy Rate in Scratching and Non Endometrial Scratching Group.

  six months

Study Arms (2)

Group A

EXPERIMENTAL

Endometrial scraching of uterine cavity by pipelle .

Procedure: Endometrial scratching

Group B

ACTIVE COMPARATOR

Uterine sound intoduced into uterine cavity without scratch .

Procedure: Endometrial scratching

Interventions

Endometrial scratching PROCEDURE

Group A: pipelle Group B: sound

Also known as: Unexplained Infertility

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Regular menstruation with the length of the cycle between 21-35 days. 3. Ovulation confirmed by appropriately timed mid-luteal progesterone. 4. Fertile semen variables (according to world health organization criteria 2010).
• \. Bilateral tubal patency (demonstrated by laparoscopy or hystrosalpingography).

You may not qualify if:

• Pelvic pathology as PID or uterine fibroids. 8- No previous history or planning for IVF. 9- Unwilling to comply with the protocol. 10- Participation in another clinical trial in the last 3 months prior to the start of this study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

RECRUITING

Study Officials

• Ahmed E Elbohoty, MD

  OB GYN Department, faculty of Medicine, ASU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anhar mohamed Ali Shehata, M.B.B.Ch

CONTACT

01005764423; doc_anhar@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in OB GYN

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 12, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

EG (1)