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

NCT ID: NCT02635425

Last Updated: 2016-05-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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7 eggs collection

Aspiration of 7 eggs only

Group Type EXPERIMENTAL

7 eggs collection

Intervention Type PROCEDURE

vaginal US

Full eggs collection

Aspiration of all eggs

Group Type ACTIVE_COMPARATOR

Full eggs collection

Intervention Type PROCEDURE

vaginal US

Interventions

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7 eggs collection

vaginal US

Intervention Type PROCEDURE

Full eggs collection

vaginal US

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ahmad Hussieny Salama

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Hussieny Salama

Associate professor at ainshams university in cairo

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed H Salama, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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LFOHSS

Identifier Type: -

Identifier Source: org_study_id

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