Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

Embryo Implantation Clinical Trial

Official title:

Evaluation of Implantation and Clinical Pregnancy After Intrauterine Flushing of Infertile Patients With Follicular Fluid Plus Granulosa Cells- Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077970
• Other study ID #: Infertility-Uterine flushing
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2023
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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 and antagonist 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. Male factor infertility with azoospermia

6. Low/Poor Response

7. Myoma with a compression effect or submocusa myometrium

8. Intra mural or subserouse Myoma > 5cm

9. Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection.

10. Endometrial tuberculosis

11. The follicular fluid which contains any oocyte or contaminated with blood will be discarded

Related Conditions & MeSH terms

• Embryo Implantation
• Flushing
• Follicular Fluid
• Granulosa Cell

Intervention

Biological:
• Intrauterine flushing of follicular fluid with granulosa cells
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 ß-hCG level and later was confirmed by Transvaginal sonography.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rates	Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred	Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])
Secondary	Clinical pregnancy rate	The observation of gestational sac on ultrasound examination two-three weeks after positive serum ßhCG	4-6 weeks after embryo transfer