Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

NCT04077970 | Completed Phase 3

• 1 other identifier: Infertility-Uterine flushing
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Follicular Fluid; Granulosa Cell; Embryo Implantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical pregnancy rate

  4-6 weeks after embryo transfer

Study Arms (2)

Intrauterine flushing follicular fluid

EXPERIMENTAL

Women underwent intrauterine flushing with follicular fluid plus granulosa cells

Biological: Intrauterine flushing of follicular fluid with granulosa cells

Without intrauterine flushing with follicular fluid

NO INTERVENTION

Women without intrauterine flushing with follicular fluid

Interventions

Intrauterine flushing of follicular fluid with granulosa cells 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.

Intrauterine flushing follicular fluid

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal Hormonal profile (FSH, LH, AMH) and normal AFC
• Normal ovarian reserve
• Age 20-38 years
• Regular menstrual cycle
• IVF / ICSI or IVF or ICSI cycles with agonist and antagonist protocol
• Existence of at least 2 oocytes in dominant follicular fluids

You may not qualify if:

• Presence of Endometriosis and Endometrioma
• Hydrosalpinx
• OHSS (Ovarian Hyper Stimulating Syndrome)
• Tubal factor infertility
• Male factor infertility with azoospermia
• Low/Poor Response
• Myoma with a compression effect or submocusa myometrium
• Intra mural or subserouse Myoma \> 5cm
• Presence of untreated Thyroid, Diabetic and Hepatitis diseases, vaginal infection.
• Endometrial tuberculosis
• The follicular fluid which contains any oocyte or contaminated with blood will be discarded

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

• 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.

  PMID: 39033367 DERIVED

Study Officials

• Maryam Hafezi

  Department of Endocrinology and Female Infertility

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2019
• First Posted: September 4, 2019
• Study Start: November 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

IR (1)