Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

Overview

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.

Full Title of Study: “Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 1, 2020

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 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.

Interventions

  • Biological: Intrauterine flushing of follicular fluid with granulosa cells
    • All patients in case and control groups will receive GnRH agonist 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. After explaining the procedure and taking informed consent from the patients: 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.

Arms, Groups and Cohorts

  • Experimental: Intrauterine flushing follicular fluid
    • Women underwent intrauterine flushing with follicular fluid plus granulosa cells
  • No Intervention: Without intrauterine flushing with follicular fluid
    • Women without intrauterine flushing with follicular fluid

Clinical Trial Outcome Measures

Primary Measures

  • Implantation rates
    • Time Frame: Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])
    • Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred

Secondary Measures

  • Clinical pregnancy rate
    • Time Frame: 4-6 weeks after embryo transfer
    • The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Royan Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maryam Hafezi, Study Chair, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
  • Overall Contact(s)
    • Parvaneh Afsharian, +9821- 23562000, pafshar@royaninstitute.org

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