Clinical trial NCT04077970: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Follicular Fluid
Granulosa Cell
Embryo Implantation
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2019-09-04
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implantation rates
timeFrame: Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 4-6 weeks after embryo transfer
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Department of Endocrinology and Female Infertility
name: Maryam Hafezi
role: STUDY_CHAIR
References: