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Follicular Flushing in Patients With Suboptimal Responses

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ClinicalTrials.gov Identifier: NCT02277210
Recruitment Status : Terminated (poor recruitment)
First Posted : October 28, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Ernest Hung-Yu Ng, The University of Hong Kong

Brief 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.


Condition or disease Intervention/treatment Phase
Infertility Other: Flushing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 2014
Actual Primary Completion Date : June 2, 2018
Actual Study Completion Date : June 2, 2018

Arm Intervention/treatment
Placebo Comparator: Non-flushing group
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.
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.

Active Comparator: Flushing group
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.
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.




Primary Outcome Measures :
  1. ongoing pregnancy rate [ Time Frame: 10 weeks of gestation ]

Secondary Outcome Measures :
  1. number of oocytes retrieved [ Time Frame: on the day of retrieval ]
  2. number of embryo available for transfer [ Time Frame: on the day of embryo transfer ]
  3. clinical pregnancy rate [ Time Frame: 6 weeks of gestation ]
  4. operation time of the retrieval [ Time Frame: on the day of retrieval ]
  5. pain score of retrieval [ Time Frame: on the day of retrieval ]


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Ages Eligible for Study:   up to 42 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277210


Locations
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China, Hong Kong
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Ernest HY Ernest Ng, MD The University of Hong Kong
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Responsible Party: Professor Ernest Hung-Yu Ng, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02277210    
Other Study ID Numbers: UW14-428
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Infertility
Flushing
Skin Manifestations