Trial Outcomes & Findings for Aspiration of Limited Number of Follicles to Prevent Severe Ovarian Hyperstimulation Syndrome (NCT NCT02635425)

NCT ID: NCT02635425

Last Updated: 2016-05-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2016-05-19

Participant Flow

Participant milestones

Measure	7 Eggs Collection Aspiration of 7 eggs only 7 eggs collection: vaginal US	Full Eggs Collection Aspiration of all eggs Full eggs collection: vaginal US
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	7 Eggs Collection n=15 Participants Aspiration of 7 eggs only 7 eggs collection: vaginal US	Full Eggs Collection n=15 Participants Aspiration of all eggs Full eggs collection: vaginal US	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	7 Eggs Collection n=15 Participants Aspiration of 7 eggs only 7 eggs collection: vaginal US	Full Eggs Collection n=15 Participants Aspiration of all eggs Full eggs collection: vaginal US
Number of Participants of Severe Ovarian Hyperstimulation Syndrome	2 participants	11 participants

Adverse Events

7 Eggs Collection

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Full Eggs Collection

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	7 Eggs Collection n=15 participants at risk Aspiration of 7 eggs only 7 eggs collection: vaginal US	Full Eggs Collection n=15 participants at risk Aspiration of all eggs Full eggs collection: vaginal US
Respiratory, thoracic and mediastinal disorders respiratory depression	13.3% 2/15 • Number of events 2	46.7% 7/15 • Number of events 7

Other adverse events

Measure	7 Eggs Collection n=15 participants at risk Aspiration of 7 eggs only 7 eggs collection: vaginal US	Full Eggs Collection n=15 participants at risk Aspiration of all eggs Full eggs collection: vaginal US
Renal and urinary disorders oliguria	0.00% 0/15	46.7% 7/15

Additional Information

Dr. Ahmad Hussieny Salama

Ain Shams university

Phone: 00201223114626

Email: ahmdhsf@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place