Trial Outcomes & Findings for Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes (NCT NCT01040351)

NCT ID: NCT01040351

Last Updated: 2011-08-29

Results Overview

The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 110 participants
• Primary outcome timeframe: 5 weeks after embryo transfer
• Results posted on: 2011-08-29

Participant Flow

This study was two arm prospective randomized controlled study including 110 fresh IVF- ETs from 110 patients , undertaken between October 2006 to May 2010 at the assisted conception unit of Ahmed Elgazzar hospital , Cairo , Egypt.

Participant milestones

Measure	1: Hydrosalpinx Needle Aspiration After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .	2. no Aspiration IVF-ET is done without prior aspiration of hydrosalpingeal fluid
Overall Study STARTED	55	55
Overall Study COMPLETED	54	53
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	1: Hydrosalpinx Needle Aspiration After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .	2. no Aspiration IVF-ET is done without prior aspiration of hydrosalpingeal fluid
Overall Study poor ovarian response	1	2

Baseline Characteristics

Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes

Baseline characteristics by cohort

Measure	1: Hydrosalpinx Needle Aspiration n=55 Participants After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .	2. no Aspiration n=55 Participants IVF-ET is done without prior aspiration of hydrosalpingeal fluid	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	55 Participants n=93 Participants	55 Participants n=4 Participants	110 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	28.16 years STANDARD_DEVIATION 3.6 • n=93 Participants	29.38 years STANDARD_DEVIATION 4.0 • n=4 Participants	28.77 years STANDARD_DEVIATION 3.86 • n=27 Participants
Sex: Female, Male Female	55 Participants n=93 Participants	55 Participants n=4 Participants	110 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment Egypt	55 participants n=93 Participants	55 participants n=4 Participants	110 participants n=27 Participants

PRIMARY outcome

Timeframe: 5 weeks after embryo transfer

Population: Patients undergoing embryo transfer were included in final analysis

The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound

)in a transfer cycle

Outcome measures

Measure	1: Hydrosalpinx Needle Aspiration n=54 Participants After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .	2. no Aspiration n=53 Participants IVF-ET is done without prior aspiration of hydrosalpingeal fluid
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle	17 participents	7 participents

SECONDARY outcome

Timeframe: 18 weeks after embryo transfer

Population: Patients who underwent embryo transfer were included in the final analysis

The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .

Outcome measures

Measure	1: Hydrosalpinx Needle Aspiration n=54 Participants After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .	2. no Aspiration n=53 Participants IVF-ET is done without prior aspiration of hydrosalpingeal fluid
The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .	15 participents	5 participents

Adverse Events

1: Hydrosalpinx Needle Aspiration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2. no Aspiration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	1: Hydrosalpinx Needle Aspiration n=54 participants at risk Aspiration of hydrosalpingeal fluid prior to IVF-ET	2. no Aspiration n=53 participants at risk IVF-ET without any prior intervention
Reproductive system and breast disorders Flaring of pelvic infection and peritonitis	0.00% 0/54 • October 2006 to May 2010	0.00% 0/53 • October 2006 to May 2010

Other adverse events

Measure	1: Hydrosalpinx Needle Aspiration n=54 participants at risk Aspiration of hydrosalpingeal fluid prior to IVF-ET	2. no Aspiration n=53 participants at risk IVF-ET without any prior intervention
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	0.00% 0/54 • October 2006 to May 2010	0.00% 0/53 • October 2006 to May 2010

Additional Information

Usama M.Fouda, M.D, PhD

Cairo university

Phone: +20123595106

Email: umfrfouda@yahoo.com

Results disclosure agreements

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