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NCT Number: NCT04077970

Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells

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.

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Key information

Conditions

Follicular Fluid Embryo Implantation Granulosa Cell

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Implantation rates

    Time frame: Day 35-42 post ovum pick-up (OPU) (34-36 hours post recombinant human choriogonadotropin day [approximately 28 days])

    Implantation rate was measured as the number of gestational sacs observed, divided by the number of embryos transferred

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 4-6 weeks after embryo transfer

    The observation of gestational sac on ultrasound examination two-three weeks after positive serum βhCG

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 4, 2019
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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