Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Hormonal monitoring impact on overall pregnancy rate in frozen embryo transfer (FET)cycles
      and hence progesterone supplement adjustments remain debatable in current literature. This
      prospective randomized study aims to investigate the effect of monitoring and follow-up of
      serum progesterone, estradiol & luteinizing hormone (LH) levels and progesterone supplement
      adjustments on pregnancy outcomes for FET in programmed hormonal replacement therapy cycles
      in comparison with ultrasound only in control group
    

Detailed description: 
      Progesterone (P4) is a steroidal hormone that is required for successful embryo implantation
      and maintenance of the pregnancy in natural cycles, fresh in vitro fertilization cycles, and
      frozen embryo transfer (FET) cycles. Women undergoing FET in programmed cycle are unable to
      provide adequate endogenous P4 and require progesterone supplementation to initiate and
      maintain the secretory endometrium and pregnancy. There has been previous research into
      luteal phase support in frozen cycles, which has demonstrated that supplementation of
      progesterone does impact outcome in FET. Despite this evidence for the role of progesterone,
      there is surprisingly little data on the optimal values for serum P4 during the luteal phase
      and specifically on the day of embryo transfer in frozen cycles. Following years of a
      prevalent belief that the higher values of P4 are better, it seems that there may be an
      optimal window for P4 values during the luteal phase in bovine IVF. Though progesterone
      levels on the day of transfer have not yet been studied extensively in humans, tailoring the
      time of transferring a frozen embryo based on serial P4 values rather than cycle day number
      alone results in higher pregnancy rates. By direct action on the endometrium, a rise of LH
      might interfere with endometrial receptivity during a FET cycle, in which no pituitary
      suppression is used. The significance of LH level on the day before addition of progesterone
      is not yet well defined. The aim of this study is to investigate the effect of monitoring and
      follow-up of serum progesterone, estradiol & luteinizing hormone levels on day of embryo
      transfer on pregnancy outcomes for FET in programmed HRT cycles in comparison with ultrasound
      only in control group and to evaluate the effect of progesterone supplements adjustments
      depending on serum progesterone levels on day of FET in affecting clinical pregnancy rate.
    

Intervention name(s): estradiol valerate; Hormonal monitoring progesterone, estradiol, luteinizing hormone; transvaginal ultrasound examination; Progesterone 400 Mg Vaginal Suppository; Hormonal monitoring progesterone and estradiol; Progesterone
Intervention type(s): Drug; Other; Diagnostic Test; Drug; Other; Drug
Intervention description(s): 8mg orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle then assess by ultrasound; Serum Progesterone, estrogen & LH measured on day 13 after priming endometrium with 8mg estradiol valerate on a daily basis beginning as early as the first day of menstrual cycle.; Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation; Progesterone supplements given in form of daily two vaginal prontogest suppositories400 mg each; Measuring the serum Progesterone & Estradiol in the early morning on the day of embryo transfer an progesterone supplementation adjusted as follows: Group II A: If P4 levels < 5ng/dl, one 100 mg intramuscular injection daily added, Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added. Group II C: If P4 levels >10ng, continued on 400 mg prontogest suppositories twice daily; group II A: 100 mg intramuscular injection daily Group II B: If P4 levels 5-10ng/dl dydrogesterone added
Other intervention name(s): Progenova; P4, E2, LH; prontogest 400 mg vaginal suppository; P4 and E2; prontogest Intramuscular injection, duphaston tab
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Hormones; Estradiol; Polyestradiol phosphate; Progesterone; Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hormonal monitoring; Frozen embryos; Progesterone; estradiol