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Aspiration of Limited Number of Follicles to Prevent Severe Ovarian Hyperstimulation Syndrome

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
7 eggs collection
Full eggs collection
Sponsored by
Ahmad Hussieny Salama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. More than 9 days of induction of ovulation.
  2. Each ovary contains more than 20 follicles.
  3. The majority of follicles are >14mm in diameter.
  4. Mild fluid in Douglas pouch.
  5. The patient started to complain of considerable lower abdominal pains before the egg collection.

Exclusion Criteria:

  1. Recurrent ICSI failure or bad obstetric history.
  2. Any medical disorder affecting the fluid shift as: diabetes mellitus, autoimmune diseases, hepatic, renal or cardiac conditions.

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

7 eggs collection

Full eggs collection

Arm Description

Aspiration of 7 eggs only

Aspiration of all eggs

Outcomes

Primary Outcome Measures

Number of Participants of Severe Ovarian Hyperstimulation Syndrome

Secondary Outcome Measures

Full Information

First Posted
December 12, 2015
Last Updated
April 19, 2016
Sponsor
Ahmad Hussieny Salama
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1. Study Identification

Unique Protocol Identification Number
NCT02635425
Brief Title
Aspiration of Limited Number of Follicles to Prevent Severe Ovarian Hyperstimulation Syndrome
Official Title
Aspiration of Limited Number of Eggs to Prevent Severe OHSS in Suspected Cases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmad Hussieny Salama

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve 7eggs only in prevention of severe ovarian hyperstimulation syndrome.
Detailed Description
Thirty patients will be selected for this study grouped into two groups, each group contains fifteen patients. Group 1 :study group ( retrieval of 7 eggs only). Group 2 :control group ( retrieval of all eggs). Study is held to compare between the two arms, the proportion of patients who will be prevented from the progression to severe OHSS after this interventional method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7 eggs collection
Arm Type
Experimental
Arm Description
Aspiration of 7 eggs only
Arm Title
Full eggs collection
Arm Type
Active Comparator
Arm Description
Aspiration of all eggs
Intervention Type
Procedure
Intervention Name(s)
7 eggs collection
Intervention Description
vaginal US
Intervention Type
Procedure
Intervention Name(s)
Full eggs collection
Intervention Description
vaginal US
Primary Outcome Measure Information:
Title
Number of Participants of Severe Ovarian Hyperstimulation Syndrome
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: More than 9 days of induction of ovulation. Each ovary contains more than 20 follicles. The majority of follicles are >14mm in diameter. Mild fluid in Douglas pouch. The patient started to complain of considerable lower abdominal pains before the egg collection. Exclusion Criteria: Recurrent ICSI failure or bad obstetric history. Any medical disorder affecting the fluid shift as: diabetes mellitus, autoimmune diseases, hepatic, renal or cardiac conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed H Salama, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
1156
Country
Egypt

12. IPD Sharing Statement

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