Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles

Asymptomatic Diseases Clinical Trial

Official title:

Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02345837
• Other study ID #: menoufia ob/gyn
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2015
• Last updated: April 4, 2016
• Start date: February 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Al Hayat National Hospital
• Contact: mohamed maher
• Phone: +966558198655
• Email: mohamaher2015[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.

Description:

Patients will be randomized using a list of computer generated random sample into two groups:

Group 1: Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.

Group 2: Couples who will undergo ovulation induction with clomiphene citrate. The drug chosen for ovulation induction in both groups will be clomephine citrate.

Timing and technique of endometrial sampling:

Timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. Technique:

this will be done using the pipelle method (Williams et al., 2008).

The procedure is as follows:

1. Vaginal speculum to expose the uterine cervix then sterilization by saline.

2. The piston positioned at the extreme distal end of the sheath then the Pipelle is inserted gently through the cervical canal into the cavity of the uterus.

3. While holding the sheath in position with one hand, the other hand rapidly pulls the piston firmly and without interruption.

4. A negative pressure within the sheath will draw the tissue into the curette opening at the distal end of the sheath and captures the separated tissue within its lumen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Male partner should have a normal semen count and motility according to world health organization criteria (Murray et al., 2012).

2. Primary, secondary or unexplained infertility for at least one year.

3. Failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles.

4. Age varies from 20-35 years with at least one year of infertility.

5. Body mass index between 19-30 kg/m2.

6. Day 2 serum FSH< 12 IU/ml.

7. Normal uterine cavity on hystrosalpingography.

8. At least one patent tube of normal appearance on HSG.

9. No previous attempts of intrauterine insemination (IUI) or in vitro fertilization (IVF).

Exclusion Criteria:

1. Infertility due to tubal factor or male factor.

2. Intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope.

3. Hypogonadotrophic hypogonadism.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asymptomatic Diseases

Intervention

Device:
• endometrial sampling
injury to the endometrium

Drug:
• clomiphene citrate
ovulation induction by 100mg clomiphene citrate

Locations

Country	Name	City	State
Egypt	Menoufia University	Shebin Elkom

Sponsors (2)

Lead Sponsor	Collaborator
Al Hayat National Hospital	Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate.		one year	Yes
Primary	Miscarriage rate.		one year	Yes
Primary	Multiple pregnancy rates		one year	Yes