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

Infertility Clinical Trial

Official title:

Aspiration of Limited Number of Eggs to Prevent Severe OHSS in Suspected Cases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635425
• Other study ID #: LFOHSS
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2015
• Last updated: December 16, 2015
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Ain Shams Maternity Hospital
• Contact: Ahmed H Salama, MD
• Phone: 00201223114626
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

Description:

Thirty patients will be selected for this study grouped into two groups, each group contains fifteen patients nuts.

Group 1 :study group ( single ovarian puncture retrieving about 7 eggs only). Group 2 :control group ( retrieval of all eggs). Study is held to compare between the two arms, the promotion of patients who will be prevented from the progression to severe OHSS after this interventional method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infertility
• Ovarian Hyperstimulation Syndrome

Intervention

Procedure:
• 7 eggs collection
vaginal US
• Full eggs collection
vaginal US

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ahmad Hussieny Salama

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants of Severe ovarian hyperstimulation syndrome		2 weeks	No