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

• Sponsor: Ahmad Hussieny Salama (Other)
• Overall Status: Completed
• CT.gov ID: NCT02635425
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 7.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: 7 eggs collection; Procedure: Full eggs collection	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Aspiration of Limited Number of Eggs to Prevent Severe OHSS in Suspected Cases
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 7 eggs collection Aspiration of 7 eggs only	Procedure: 7 eggs collection; vaginal US
Active Comparator: Full eggs collection Aspiration of all eggs	Procedure: Full eggs collection; vaginal US

Outcome Measures

Primary Outcome Measures

1. Number of Participants of Severe Ovarian Hyperstimulation Syndrome [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt	1156

Sponsors and Collaborators

• Ahmad Hussieny Salama

Investigators

• Principal Investigator: Ahmed H Salama, MD, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmad Hussieny Salama, Associate professor at ainshams university in cairo, Ain Shams Maternity Hospital
• ClinicalTrials.gov Identifier: NCT02635425
• Other Study ID Numbers: LFOHSS
• First Posted: Dec 18, 2015
• Last Update Posted: May 19, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Infertility

Study Results

Participant Flow

Arm/Group Title	7 Eggs Collection	Full Eggs Collection
Arm/Group Description	Aspiration of 7 eggs only 7 eggs collection: vaginal US	Aspiration of all eggs Full eggs collection: vaginal US
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	7 Eggs Collection	Full Eggs Collection	Total
Arm/Group Description	Aspiration of 7 eggs only 7 eggs collection: vaginal US	Aspiration of all eggs Full eggs collection: vaginal US	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	15 100%	30 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	15 100%	15 100%	30 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants of Severe Ovarian Hyperstimulation Syndrome
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	7 Eggs Collection	Full Eggs Collection
Arm/Group Description	Aspiration of 7 eggs only 7 eggs collection: vaginal US	Aspiration of all eggs Full eggs collection: vaginal US
Measure Participants	15	15
Number [participants]	2 13.3%	11 73.3%

Adverse Events

Arm/Group Title	7 Eggs Collection		Full Eggs Collection
Arm/Group Description	Aspiration of 7 eggs only 7 eggs collection: vaginal US		Aspiration of all eggs Full eggs collection: vaginal US
All Cause Mortality
	7 Eggs Collection		Full Eggs Collection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	7 Eggs Collection		Full Eggs Collection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)		7/15 (46.7%)
Respiratory, thoracic and mediastinal disorders
respiratory depression	2/15 (13.3%)	2	7/15 (46.7%)	7
Other (Not Including Serious) Adverse Events
	7 Eggs Collection		Full Eggs Collection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		7/15 (46.7%)
Renal and urinary disorders
oliguria	0/15 (0%)		7/15 (46.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.