Effect of Laparoscopic Ovarian Drilling on Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome

May 6, 2018 updated by: rabab adel kamal, Ain Shams University

Effect of Laparoscopic Ovarian Drilling on the Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome

the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. this study is undertaken to evaluate the in vitro fertilisation outcomes in clomiphene-resistant women with PCOS who were treated with LOD.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

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 Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

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

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age between 25 and 35
  • patients with established PCOS
  • history at least one year infertility
  • no response to clomiphene citrate for at least three cycles

Exclusion Criteria:

  • history of previous IVF/ICSI
  • chronic disease such as thyroid disorder and DM
  • infertility due to sever male factor
  • sever endometriosis
  • infertility due to uterine factor such as multiple fibroid
  • body mass index > 30

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PCOS women with history of LOD before IVF/ICSI
Procedure: IVF/ICSI
IVF/ICSI
Active Comparator: PCOS women without history of drilling
Procedure: IVF/ICSI
IVF/ICSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound
Time Frame: 3 months
Pregnancy confirmed by b-hcg and visualization of gestational sac by ultrasound
3 months

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 (Actual)

March 1, 2018

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

April 19, 2018

First Submitted That Met QC Criteria

May 6, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 6, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rkamal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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