NCT03527979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

April 19, 2018

Last Update Submit

May 6, 2018

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound

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

    3 months

Study Arms (2)

PCOS women with history of LOD before IVF/ICSI

ACTIVE COMPARATOR
Procedure: IVF/ICSI

PCOS women without history of drilling

ACTIVE COMPARATOR
Procedure: IVF/ICSI

Interventions

IVF/ICSIPROCEDURE

IVF/ICSI

PCOS women with history of LOD before IVF/ICSIPCOS women without history of drilling

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ob/gyn resident

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 17, 2018

Study Start

March 1, 2018

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

EG(1)