Human Chorionic Gonadotrophin in an Antagonist Protocol
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A novel gonadotropin protocol for ovarian stimulation adds low-dose hCG (50- 200 IU) as a
      source of LH (luteinizing hormone) in the late follicular phase .

      This regimen reduces the number of small pre-ovulatory follicles which could reduce the risk
      of OHSS(ovarian hyper stimulation syndrome). Adequate ovarian hormonal levels , oocyte
      maturation, avoidance of a premature LH surge, and increased pregnancy rate are the other
      benefits of this regimen.

      HCG might also affect endometrial function, stimulate endometrial growth and maturation and
      enhance the endometrial angiogenesis. These effects could extend the angiogenesis. These
      results could lengthen the implantation Window.

      Inhibin A is a heterodimer protein and does not begin to increase until just after the
      increase in oestradiol in the late follicular phase, suggesting secretion by the dominant
      follicle. Inhibin A secretion is regulated by LH and is associated with paracrine/autocrine
      action on oocyte maturation. Moreover, it is related to follicular development and size,
      serving as a marker of follicular maturation after IVF cycles .However, the role of hCG
      supplementation during COH (controlled ovarian hyperstimulation)is still a matter of debate
      and more studies is needed. Thus, the objective of this trial was to investigate whether LH
      activity in the form of low dose hCG in GnRH (Gonadotropin releasing hormone)antagonist
      cycles would improve the quality of oocytes, level of inhibin A and endometrial vascularity.
    

Detailed description: 
      -  60 women, where 30 of them will receive low dose HCG with rFSH (group 1), while the
           other 30 women will receive rFSH (Recombinant Follicle stimulating Hormone) with a
           placebo (group 2) both using the antagonist protocol as a method of induction in ICSI.

        -  Women in both groups will be treated with a GnRH antagonist protocol with
           cetrotide(cetrorelix)

        -  In Group 1, low dose hCG (200 IU per day) with rFSH will be given daily when at least
           six follicles of 12 mm will be observed and E2 levels are higher than 600 ng/l, until
           the day of the hCG trigger administration.

        -  Group 2 patients received rFSH injections with a placebo starting on cycle day 3 of the
           stimulation cycle until the day of hCG trigger administration.

      In both groups Oocytes will be retrieved 36 h after the hCG trigger shot. All mature eggs
      retrieved will be fertilized with intracytoplasmic sperm injection (ICSI). Fertilization will
      be checked at 18 hours post insemination. Embryo quality will be assessed and embryo transfer
      will occur at day 3.
    

Intervention name(s): Low dose HCG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Low dose hCG (200 IU per day) will be given daily when at least six follicles of 12 mm will be observed and E2 (Estradiol) levels are higher than 600 ng/l, until the day of the HCG trigger administration.; Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.
Other intervention name(s): Human chorionic gonadotrophin; saline 0.9%
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment