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

Not Applicable

• Conditions: Asymptomatic Diseases
• Interventions: Drug: clomiphene citrate; Device: endometrial sampling

• Registration Number: NCT02345837
• Lead Sponsor: Al Hayat National Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-26
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clomiphene citrate	clomiphene citrate	Couples who will undergo ovulation induction with clomiphene citrate.
clomiphene and endometrial sampling	endometrial sampling	Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.
clomiphene and endometrial sampling	clomiphene citrate	Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate.	one year
Miscarriage rate.	one year
Multiple pregnancy rates	one year

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shebin Elkom, Egypt