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

Abstract

Background: The follicular fluid (FF) of mature oocytes contains a high concentration of growth factors and cytokinesthat have the potential to influence implantation in either a paracrine or autocrine manner. During the physiologicalprocesses of ovulation, FF enters the fallopian tubes in conjunction with the oocyte. The purpose of this studyis to evaluate implantation and clinical pregnancy rates following uterine flushing with FF and granulosa cells ininfertile women with moderate male factor infertility after ovum retrieval for intracytoplasmic sperm injection (ICSI).Materials and Methods: This phase III randomised clinical trial enrolled 140 women with moderate male factorinfertility who intended to undergo ICSI at Royan Infertility Clinic (Tehran, Iran). A computer-generated program andopaque sealed envelopes were used to randomly allocate patients to either an intervention group (n=70) or a controlgroup (n=70). Participants in the intervention group received 2 ml of clear FF (without blood contamination) from 2to 3 dominant follicles after oocyte retrieval. The control group only underwent uterine cavity catheterisation.Results: The intervention group had a clinical pregnancy rate of 38.5% (25/65) compared to the control group [42.9%(27/63); P=0.719] and an implantation rate of 24.1% compared to the control group (27%; P=0.408). These rates did notdiffer between the groups. There were no statistically significant differences between the intervention and control groupsin terms of pregnancy-related complications-ectopic pregnancy, blighted ovum or anembryonic pregnancy, and abortion.Conclusion: Uterine cavity flushing with FF from mature follicles following oocyte retrieval had no effect, eitherpositively or negatively, on clinical pregnancy or implantation rates in women with moderate male factor infertility(registration number: NCT04077970).

Keywords

• clinical pregnancy
• endometrial receptivity
• follicular fluid
• granulosa cell
• implantation