NCT02635425

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 19, 2016

Completed
Last Updated

May 19, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

December 12, 2015

Results QC Date

March 21, 2016

Last Update Submit

April 19, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of Participants of Severe Ovarian Hyperstimulation Syndrome

    2 weeks

Study Arms (2)

7 eggs collection

EXPERIMENTAL

Aspiration of 7 eggs only

Procedure: 7 eggs collection

Full eggs collection

ACTIVE COMPARATOR

Aspiration of all eggs

Procedure: Full eggs collection

Interventions

7 eggs collectionPROCEDURE

vaginal US

7 eggs collection
Full eggs collectionPROCEDURE

vaginal US

Full eggs collection

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 1156, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Results Point of Contact

Title
Dr. Ahmad Hussieny Salama
Organization
Ain Shams university
ahmdhsf@hotmail.com
00201223114626

Study Officials

  • Ahmed H Salama, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor at ainshams university in cairo

Study Record Dates

First Submitted

December 12, 2015

First Posted

December 18, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 19, 2016

Results First Posted

April 19, 2016

Record last verified: 2016-04

Locations

EG(1)