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Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

Primary Purpose

Follicular Fluid, Granulosa Cell, Embryo Implantation

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intrauterine flushing of follicular fluid with granulosa cells
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Fluid

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Normal Hormonal profile (FSH, LH, AMH) and normal AFC
  2. Normal ovarian reserve
  3. Age 20-38 years
  4. Regular menstrual cycle
  5. IVF / ICSI or IVF or ICSI cycles with Agonist Protocol
  6. Existence of at least 2 oocytes in dominant follicular fluids

Exclusion Criteria:

  1. Presence of Endometriosis and Endometrioma
  2. Hydrosalpinx
  3. OHSS (Ovarian Hyper Stimulating Syndrome)
  4. Tubal factor infertility
  5. Age <38 years old
  6. Male factor infertility with azoospermia
  7. Low/Poor Response
  8. Myoma with a compression effect or submocusa myometrium
  9. Intra mural or subserouse Myoma > 5cm
  10. Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection.
  11. Endometrial tuberculosis
  12. Patients with any special drug intake
  13. The follicular fluid which contains any oocyte or contaminated with blood will be discarded

Sites / Locations

  • Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intrauterine flushing follicular fluid

Without intrauterine flushing with follicular fluid

Arm Description

Women underwent intrauterine flushing with follicular fluid plus granulosa cells

Women without intrauterine flushing with follicular fluid

Outcomes

Primary Outcome Measures

Implantation rates
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred

Secondary Outcome Measures

Clinical pregnancy rate
The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG

Full Information

First Posted
September 1, 2019
Last Updated
March 11, 2023
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04077970
Brief Title
Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells
Official Title
Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
One hundred forty patients with male factor infertility are randomized into two groups. In the study group, flushing the endometrial cavity with 2ml of clear follicular fluid with granulose cells will be performed using an IUI catheter after ovum pick-up While in the control group, no flushing of the endometrial cavity with FF is done. The implantation rates and pregnancy rates in both groups will be assessed.
Detailed Description
This study is a randomized clinical trial to investigate implantation rate and clinical pregnancy after intrauterine flushing of infertile patients with follicular fluid plus granulosa cells - Randomized controlled trials. The study protocol is approved by the Ethics Committee (Institutional Review Board) of Royan institute and all participants provide informed consent. The main objective of this study is evaluation of implantation rate and clinical pregnancy after flushing of uterine in infertile patients with follicular fluid plus granulosa cells in IVF/ ICSI cycles. Material and methods: In a randomized clinical trial, 140 patients with Male factor infertility referring to infertility clinic of Royan Institute, Iran, who received ovarian stimulation with antagonist and agonist protocol, will be randomly assigned to two groups: in case group, if the follicular fluid of two clear dominant follicles contain at least 2 COC, after removal of the COCs, follicular fluid will be collected Endometrial cavity flushing with 2 ml of follicular fluid will be performed by IUI caterer. In control group only catheterization of uterine cavity will be performed. Primary outcome is comparison of implantation rate between case and control group. Secondly outcome is assessment of clinical pregnancy rate in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Fluid, Granulosa Cell, Embryo Implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrauterine flushing follicular fluid
Arm Type
Experimental
Arm Description
Women underwent intrauterine flushing with follicular fluid plus granulosa cells
Arm Title
Without intrauterine flushing with follicular fluid
Arm Type
No Intervention
Arm Description
Women without intrauterine flushing with follicular fluid
Intervention Type
Biological
Intervention Name(s)
Intrauterine flushing of follicular fluid with granulosa cells
Intervention Description
All patients in case and control groups will receive agonist and antagonist protocol. Ovarian stimulation will be carried out when pituitary desensitization is achieved and is continued until the day of hCG administration. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. Endometrial flushing after oocyte retrieval with 2 ml of clear FF plus granulose cells will be performed by an IUI catheter. The control group included 70 women who would not have FF endometrial flushing. In both groups, embryo transfer will be carried out 2-3 days later. Luteal phase support will be started the day after ovum pick up by the vaginal administration of progesterone daily for 16 days and will continued for up to12 weeks if pregnancy occurred. Pregnancy was diagnosed by measurement of β-hCG level and later was confirmed by Transvaginal sonography.
Primary Outcome Measure Information:
Title
Implantation rates
Description
Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred
Time Frame
Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG
Time Frame
4-6 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal Hormonal profile (FSH, LH, AMH) and normal AFC Normal ovarian reserve Age 20-38 years Regular menstrual cycle IVF / ICSI or IVF or ICSI cycles with agonist and antagonist protocol Existence of at least 2 oocytes in dominant follicular fluids Exclusion Criteria: Presence of Endometriosis and Endometrioma Hydrosalpinx OHSS (Ovarian Hyper Stimulating Syndrome) Tubal factor infertility Male factor infertility with azoospermia Low/Poor Response Myoma with a compression effect or submocusa myometrium Intra mural or subserouse Myoma > 5cm Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection. Endometrial tuberculosis The follicular fluid which contains any oocyte or contaminated with blood will be discarded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Hafezi
Organizational Affiliation
Department of Endocrinology and Female Infertility
Official's Role
Study Chair
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

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