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

April 4, 2016 updated by: mohamed maher, Al Hayat National Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Shebin Elkom, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: clomiphene and endometrial sampling
Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.
Device: endometrial sampling
injury to the endometrium
Drug: clomiphene citrate
ovulation induction by 100mg clomiphene citrate
Other Names:
  • clomid
Active Comparator: clomiphene citrate
Couples who will undergo ovulation induction with clomiphene citrate.
Drug: clomiphene citrate
ovulation induction by 100mg clomiphene citrate
Other Names:
  • clomid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate.
Time Frame: one year
one year
Miscarriage rate.
Time Frame: one year
one year
Multiple pregnancy rates
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Hayat National Hospital

Collaborators

Menoufia University

Investigators

  • Study Chair: menoufia university, menoufia fuculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • menoufia ob/gyn

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asymptomatic Diseases

Clinical Trials on endometrial sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe