Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

NCT ID: NCT04077970

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2023-01-01

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.

Conditions

Follicular Fluid; Granulosa Cell; Embryo Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intrauterine flushing follicular fluid

Women underwent intrauterine flushing with follicular fluid plus granulosa cells

Group Type: EXPERIMENTAL

Intrauterine flushing of follicular fluid with granulosa cells

Intervention Type: BIOLOGICAL

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.

Without intrauterine flushing with follicular fluid

Women without intrauterine flushing with follicular fluid

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 β-hCG level and later was confirmed by Transvaginal sonography.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryam Hafezi

Role: STUDY_CHAIR

Department of Endocrinology and Female Infertility

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

References

Hosseini E, Aghajanpour S, Chekini Z, Zameni N, Zolfaghary Z, Aflatoonian R, Hafezi M. An Approach to Improve Endometrial Receptivity: Is It Beneficial to Flush The Uterine Cavity with Follicular Fluid and Granulosa Cells? A Phase III Randomised Clinical Trial. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):22-29. doi: 10.22074/ijfs.2023.2000897.1461.

Reference Type: DERIVED

PMID: 39033367 (View on PubMed)

Other Identifiers

Infertility-Uterine flushing

Identifier Type: -

Identifier Source: org_study_id