Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

Royan Institute

Status and phase: Completed; Phase 3

Conditions: Embryo Implantation; Follicular Fluid; Granulosa Cell

Treatments: Biological: Intrauterine flushing of follicular fluid with granulosa cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04077970

Infertility-Uterine flushing

Details and patient eligibility

About

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 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.

Enrollment: 140 patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: Accepts 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Intrauterine flushing follicular fluid

Experimental group

Description:

Women underwent intrauterine flushing with follicular fluid plus granulosa cells

Treatment:

Biological: Intrauterine flushing of follicular fluid with granulosa cells

Without intrauterine flushing with follicular fluid

No Intervention group

Description:

Women without intrauterine flushing with follicular fluid