Endometrial Follicular Fluid Flushing and IVF Outcome
Primary Purpose
Clinical Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
follicular fluid flushing
Sponsored by
About this trial
This is an interventional treatment trial for Clinical Pregnancy
Eligibility Criteria
inclusion criteria:age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. -
Exclusion Criteria:previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility.
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
İntracavitary fluid flushing
Control group
Arm Description
Outcomes
Primary Outcome Measures
Clinical pregnancy
intrauterine pregnancy with metal cardiac activity
Secondary Outcome Measures
Full Information
NCT ID
NCT04479059
First Posted
March 12, 2020
Last Updated
July 18, 2020
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04479059
Brief Title
Endometrial Follicular Fluid Flushing and IVF Outcome
Official Title
Endometrial Follicular Fluid Flushing and IVF Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objective: In this study, our aim will be investigating the pregnancy results in unexplained infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid, that we maintain mature follicules inside them in oocyte retrieval day.
Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro Fertilization Center between October 2016 to May 2017 will be randomized with computer generated programme. The patients will be divided into two groups; follicular fluid group (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the study programme. The exclusion criteria are determined as below: previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility.
Detailed Description
Objective: In this study, our aim will be investigating the pregnancy results in unexplained infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid, that we maintain mature follicules inside them in oocyte retrieval day.
Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro Fertilization Center between October 2016 to May 2017 will be randomized with computer generated programme. The patients will be divided into two groups; follicular fluid group (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the study programme. The exclusion criteria are determined as below: previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
İntracavitary fluid flushing
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
follicular fluid flushing
Intervention Description
Follicular fluid obtained during OPU will be used for endometrial cavity flushing.
Primary Outcome Measure Information:
Title
Clinical pregnancy
Description
intrauterine pregnancy with metal cardiac activity
Time Frame
during last 24 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
infertile women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
inclusion criteria:age between 20-39 years, basal FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin (hCG) day between 1000-4000 pg/ml. -
Exclusion Criteria:previously diagnosed endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history of implantation failure in IVF/ICSI cycles and severe male factor infertility.
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endometrial Follicular Fluid Flushing and IVF Outcome
We'll reach out to this number within 24 hrs