Endometrial Follicular Fluid Flushing and IVF Outcome

Clinical Pregnancy Clinical Trial

Official title:

Endometrial Follicular Fluid Flushing and IVF Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479059
• Other study ID #: Ebru Cogendez
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2020
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Clinical Pregnancy
• Flushing

Intervention

Other:
• follicular fluid flushing
Follicular fluid obtained during OPU will be used for endometrial cavity flushing.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	intrauterine pregnancy with metal cardiac activity	during last 24 months