Clincosm LogoSign in Get a demo

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

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03527979
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
14.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: IVF/ICSI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Effect of Laparoscopic Ovarian Drilling on the Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound [3 months]

    Pregnancy confirmed by b-hcg and visualization of gestational sac by ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams university Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
rabab adel kamal, ob/gyn resident, Ain Shams University
ClinicalTrials.gov Identifier:
NCT03527979
Other Study ID Numbers:
  • rkamal
First Posted:
May 17, 2018
Last Update Posted:
May 17, 2018
Last Verified:
May 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Polycystic Ovary Syndrome

Study Results

No Results Posted as of May 17, 2018