Clinical Trial: Androgenic Profile Following Controlled Ovarian Stimulation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Follicular Fluid, Serum Endocrine Profile Following Stimulation With Recombinant Gonadotropins or Highly Purified Human Menopausal Gonadotropin During GnRH-antagonist Protocol

Brief Summary: In this study the investigators will try to discover whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of androgenic hormones profile. The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity.

Detailed Summary:

ABSTRACT:

The optimal controlled ovarian stimulation (COH) protocol is yet to be decided and most probably there is no right protocol that is optimal for all patients.

The role of luteinizing hormone (LH) administration during controlled ovarian stimulation (COH) is widely debated in the current medical literature.

Until recently the only source for exogenous LH activity was HMG preparations, however, in the past few years an advancement in the field of recombinant technology resulted in recombinant preparations of LH. In contrast to LH activity in HMG which is mainly due to hCG rather than from LH, using r-LH provides true, consistent and precise LH activity.

In the past years few papers were published about the difference between recombinant follicle stimulating hormone (r-FSH) and menotropins but there is still a need for researching the different effects of gonadotropins preparations and in particular the effect of LH administration during COH in the manner of follicular endocrine characteristics, embryo quality and pregnancy outcomes.

In the present study the investigators aim to elucidate whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles. The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity.

In the relevant medical literature there is one prospective study dealing with the same question, but, during
Sponsor: Sheba Medical Center

Current Primary Outcome:

  • Serum hormonal profile [ Time Frame: (1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration (Day-hCG); and (3) day of ovum pick-up (Day-OPU). ]
    Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone
  • Follicular fluid hormonal profile [ Time Frame: Ovum pick up day ]
    Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Implantation rate [ Time Frame: About three weeks after embryo transfer ]
    Number of gestational sacs on US exam / number of retrieved embryos
  • Clinical pregnancy [ Time Frame: About three weeks after embryo transfer ]
    Number of cases with gestational sac per US exam / cases of embryo transfer
  • Biochemical pregnancy [ Time Frame: About two weeks after embryo tranfer ]
    Positive BHCG test
  • Ongoing pregnancy [ Time Frame: 10-12 weeks after embryo tranfer ]
    Number of viable pregnancies at about 10-12 weeks of gestation
  • Live birth rate [ Time Frame: Until about 40 weeks after embryo transfer ]
    Number of pregnancies ended in a live birth
  • Number of follicles [ Time Frame: During stimulation - one-two dayes before ovum pick-up ]
    Larger than 14 mm follicles per US
  • Number of oocytes retrieved [ Time Frame: 1 day right after ovarian pick-up ]
    Number of oocytes retrieved during ovarian pick-up
  • Number of embryos [ Time Frame: About 3 days after OPU (ovum pick-up) ]
    Number of developing embryos in the laboratory
  • Number of top quality embryos [ Time Frame: 3 days after OPU ]
    The number of day 3 embryos with 7-8 cells with less than 15% fragmentation


Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: December 11, 2016
Date Started: December 2016
Date Completion: January 2020
Last Updated: December 18, 2016
Last Verified: December 2016