Endometrial Follicular Fluid Flushing and IVF Outcome

NCT ID: NCT04479059

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2017-05-31

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.

Conditions

Clinical Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

İntracavitary fluid flushing

Group Type: EXPERIMENTAL

follicular fluid flushing

Intervention Type: OTHER

Follicular fluid obtained during OPU will be used for endometrial cavity flushing.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

follicular fluid flushing

Follicular fluid obtained during OPU will be used for endometrial cavity flushing.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role: lead

Responsible Party

Faik Uzun

research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Ebru Cogendez

Identifier Type: -

Identifier Source: org_study_id