NCT04479059

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

March 12, 2020

Last Update Submit

July 18, 2020

Conditions

Clinical Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    intrauterine pregnancy with metal cardiac activity

    during last 24 months

Study Arms (2)

İntracavitary fluid flushing

EXPERIMENTAL
Other: follicular fluid flushing

Control group

NO INTERVENTION

Interventions

follicular fluid flushingOTHER

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

İntracavitary fluid flushing

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile women
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

March 12, 2020

First Posted

July 21, 2020

Study Start

October 1, 2016

Primary Completion

May 30, 2017

Study Completion

May 31, 2017

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share