Overview

This trial is active, not recruiting.

Condition infertility
Treatment flushing
Sponsor The University of Hong Kong
Start date October 2014
End date October 2016
Trial size 170 participants
Trial identifier NCT02277210, UW14-428

Summary

Oocyte aspiration under the guidance of transvaginal ultrasound is an integral part in IVF treatment. Follicular flushing has been advocated. However, subsequent data from randomized trials failed to demonstrate any benefits with routine follicular flushing in normally responding patients. Instead, it has been shown to prolong the operating time, increase the procedure-related pain and analgesics requirement. Most of the IVF centers no longer perform routine follicular flushing in normally responding patients.

The potential role of follicular flushing in patients with a limited number of developing follicles is conflicting based on the recently published randomized trials. The aim of the present study is to determine the effect of follicular flushing on the ongoing pregnancy rate in patients who developed four or fewer follicles of 14mm following standard ovarian stimulation for IVF.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Placebo Comparator)
Aspiration alone for all follicular larger than 10mm on both sides. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes.
flushing
aspiration of follicles that are larger than 10 mm on both sides followed by follicular flushing for up to 4 times. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes.
(Active Comparator)
aspiration of follicles that are larger than 10 mm on both sides followed by follicular flushing for up to 4 times. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes.
flushing
aspiration of follicles that are larger than 10 mm on both sides followed by follicular flushing for up to 4 times. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes.

Primary Outcomes

Measure
ongoing pregnancy rate
time frame: 10 weeks of gestation

Secondary Outcomes

Measure
number of oocytes retrieved
time frame: on the day of retrieval
number of embryo available for transfer
time frame: on the day of embryo transfer
clinical pregnancy rate
time frame: 6 weeks of gestation
operation time of the retrieval
time frame: on the day of retrieval
pain score of retrieval
time frame: on the day of retrieval

Eligibility Criteria

Female participants up to 42 years old.

Inclusion Criteria: 1. Age of women <43 years 2. Normal uterine cavity on saline sonogram 3. Endometrial thickness >=8mm on the day of hCG Exclusion Criteria: 1. Planned not to have fresh embryo transfer 2. Cycle cancelled prior to hCG administration 3. Natural cycle IVF 4. Presence of hydrosalpinges on scanning which are not surgically treated 5. Presence of endometrial polyps on scanning 6. Undergoing preimplantation genetic diagnosis

Additional Information

Official title Effect of Follicular Flushing on the Ongoing Pregnancy Rate in Patients Who Developed Four or Fewer Follicles of 14mm Following Standard Ovarian Stimulation for In-vitro Fertilization Treatment - A Randomized Controlled Trial.
Principal investigator Ernest HY Ernest Ng, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by The University of Hong Kong.