Endometrial Scratching by Pipelle on Pregnancy Rate in Unexplained Infertility

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Ahmed Elsayed Hassan Elbohoty, Ain Shams University
ClinicalTrials.gov Identifier:
NCT02084914
First received: March 10, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Unexplained Infertility
Procedure: Endometrial scratching
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Endometrial Scratching by Pipelle on Pregnancy Rate in Couples With Unexplained Infertility

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • Biochemical Pregnancy Rate in Scratching and Non Endometrial Scratching Group. [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 158
Study Start Date: December 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Endometrial scraching of uterine cavity by pipelle .
Procedure: Endometrial scratching
Group A: pipelle Group B: sound
Other Name: Unexplained Infertility
Active Comparator: Group B
Uterine sound intoduced into uterine cavity without scratch .
Procedure: Endometrial scratching
Group A: pipelle Group B: sound
Other Name: Unexplained Infertility

Detailed Description:

Unexplained infertility (UI) is a term used to describe infertile couples in whom standard investigations, including semen analysis, tests of ovulation and tubal patency, have failed to detect any gross abnormality (Crosignani et al., 1993). It is a diagnosis of exclusion, almost 30-40% of infertile couples would suffer from this type of subfertility (Simth et al., 2003). A diversity of causes had been hypothesized to explain the condition. Cervical, uterine, ovulatory, peritoneal, immunological, endocrinological, genetic defects and reproductive physiology disturbances had been continuously suggested as potential causative factors (Rov et al., 2005; Shveiky et al., 2006; Bellver et al., 2008; Golubovsky, 2008; Woodson, 2008). Empirically, interventions for managing unexplained infertility had been widely practiced. These interventions include expectant management, intrauterine insemination (IUI) with ovarian stimulation and in vitro fertilization (El-Toukhy & Khalaf, 2008; Bhattachary et al., 2010).

In humans, the uterus becomes receptive during the midsecretory phase of the menstrual cycle (days 19-23), commonly known as the window of implantation (WOI). It is assumed that inadequate uterine receptivity is responsible for approximately two-thirds of implantation failures (Simon et al., 1998). Since an impairment of endometrial receptivity may be a cause of subfertility in a group of couples diagnosed with unexplained infertility (Jasper et al., 2006; Boroujerdnia & Nikbakht, 2008; Konac et al., 2009). Endometrial scratching may help a group of couples with unexplained infertility.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria 1. Women diagnosed to have unexplained infertility aged between 20-35y.

2. 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).

5. Bilateral tubal patency (demonstrated by laparoscopy or hystrosalpingography).

Exclusion Criteria: 1- Patients aged less than 20 y. or more than 35y 2- Infertile semen analysis. 3- Abnormal hormonal profile (FSH level more than 10). 4- Patient diagnosed as polycystic ovary (PCO). 5- Medical disorders as hypertention,liver and renal diseases. 6- Endocrinal disorders as hyperthyroidism,hypothyroidism and diabetes mellitus.

7- 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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084914

Contacts
Contact: Anhar mohamed Ali Shehata, M.B.B.Ch 01005764423 ext 01115959740 doc_anhar@yahoo.com

Locations
Egypt
Ain Shams Maternity Hospital Recruiting
Cairo, Egypt
Contact: Ahmed E Elbohoty, MD       elbohoty79@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Ahmed E Elbohoty, MD OB GYN Department, faculty of Medicine, ASU
  More Information

No publications provided

Responsible Party: Ahmed Elsayed Hassan Elbohoty, Lecturer in OB GYN, Ain Shams University
ClinicalTrials.gov Identifier: NCT02084914     History of Changes
Other Study ID Numbers: ESBPOPRIUI
Study First Received: March 10, 2014
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ain Shams University:
endometrial scratching
pipelle
pregnancy rate
unexplained infertility

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

ClinicalTrials.gov processed this record on August 19, 2014