Intrauterine Flushing With Follicular Fluid Plus Granulosa Cells
Condition: Follicular Fluid; Granulosa Cell; Embryo Implantation
MeSH terms: Flushing
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Intrauterine flushing of follicular fluid with granulosa cells
Intervention type(s): Biological
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment