Follicular Flushing in Patients With Suboptimal Responses

Infertility Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02277210
• Other study ID #: UW14-428
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: June 2, 2018

Study information

• Verified date: July 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2, 2018
• Est. primary completion date: June 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Flushing
• Infertility

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynaecology	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy rate		10 weeks of gestation
Secondary	number of oocytes retrieved		on the day of retrieval
Secondary	number of embryo available for transfer		on the day of embryo transfer
Secondary	clinical pregnancy rate		6 weeks of gestation
Secondary	operation time of the retrieval		on the day of retrieval
Secondary	pain score of retrieval		on the day of retrieval