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CompletedNCT04479059Updated Jul 21, 2020

Endometrial Follicular Fluid Flushing and IVF Outcome

An interventional study of follicular fluid flushing in Clinical Pregnancy, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Completed. Open to female participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Clinical Pregnancy

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03

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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.

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04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    İntracavitary fluid flushing

    Other: follicular fluid flushing

  • No intervention
    Control group

Interventions

  • Otherfollicular fluid flushing

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

05

What researchers measure

Primary outcomes

  1. Clinical pregnancy

    intrauterine pregnancy with metal cardiac activity

    Time frame: during last 24 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04479059
Lead sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Responsible party
Faik Uzun (research assistant, Zeynep Kamil Maternity and Pediatric Research and Training Hospital) — Principal investigator
First posted
Jul 21, 2020
Start date
Oct 1, 2016
Primary completion
May 30, 2017
Completion
May 31, 2017
Last update
Jul 21, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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