Luteal Phase Support During Frozen Embryo Transfer Cycle
Condition: Infertility, Female; Frozen Embryo Transfer
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      We aimed to decrease quantity of exogenous estrogen and evaluated the success rate of ongoing
      pregnancy in women undergone artificial FET who have a surplus embryos at previous fertility
      treatment cycles.

      In this study, endometrial prepared with standard long GnRH protocol and for luteal phase
      support patients received 6 mg oral E2 and intramuscularly P 100 mg/d and embryos on day 2-3
      were transferred. Control group continued E2 until 12 week of pregnancy, while for cases
      after identify gestational sac with heart beat (the 6 week of pregnancy) by vaginal
      ultrasonography, E2 will discontinued.
    

Detailed description: 
      Approval Status: Confirmed Approval reference Number: IR.ACECR.ROYAN.REC.1395.70 Board Name:
      Ethics committee of Royan infertility institute Board Affiliation: Reza Samani Phone:
      +982122305236 Email: samani@royaninstitute.org

      Yes Health, Treatment and Medical Education Ministry: Iran

      Hormones replace therapy (Artificial) is a method for endometrium preparation and embryo
      transfer. In this protocol for decrease of spontaneous ovulation, exogenous estrogen began in
      2-3 days on follicular phase of the menstrual cycle which continue about 10 to 14 days. In
      the following luteal phase support by progesterone begins on 14 to 16 days of cycles. The
      luteal phase is supported with different dose and duration of estradiol (E2) and progesterone
      (P) until 8-12 week of pregnancy. Studied reported a higher risk of thromboembolism in
      pregnant women that using exogenous estrogen. Also, excess estrogen might be resulted fetus
      congenital anomalies, low birth weight and increased susceptibility to breast cancer in
      female fetuses. On the other hands, it seems placenta in early pregnancy duration synthesize
      estrogen and this time estrogen sufficient as a product of progesterone metabolism. We aimed
      to decrease quantity of exogenous estrogen and evaluated the success rate of ongoing
      pregnancy in women undergone artificial FET who have a surplus embryos at previous fertility
      treatment cycles.

      In this study, endometrial prepared with standard long GnRH protocol and for luteal phase
      support patients received 6 mg oral E2 and intramuscularly P 100 mg/d and embryos on day 2-3
      were transferred. Control group continued E2 until 12 week of pregnancy, while for cases
      after identify gestational sac with heart beat (the 6 week of pregnancy) by vaginal
      ultrasonography, E2 will discontinued.

      The level of maternal estrogen and progesterone measured at progesterone days (day 15), the
      day of embryo transfer, 6 and 12 weeks of pregnancy.

      This study is a randomized clinical trial to investigate the duration of estrogen for luteal
      phase in pregnant women undergone frozen embryo transfer cycles- Randomized controlled trials
      phase III. The study protocol is approved by the Ethics Committee (Institutional Review
      Board) of Royan institute and all participants provide informed consent.
    

Intervention name(s): Strogen; Strogen
Intervention type(s): Drug; Drug
Intervention description(s): The OCP-LD begins in 2 to 3 days of the last menstrual cycle and then 500 μgr/d GnRH-a will received on day 17 for fourteen days. Then in 2-3 days of the next menstrual cycle, GnRH-a reduced to 200 μgr/d dose. the patients will receive 6 mg oral that will be continued for 14 days and during this time endometrium thickness evaluated by vaginal ultrasonography. If endometrial thickness is estimated ≥7mm, intramuscularly progesterone 100 mg/d will be started. After the onset of progesterone (days 17 to 18 cycles) frozen embryos transferred. Control group receive 6 mg oral estrogen and 100 mg intramuscularly progesterone until 12 week of pregnancy. The levels of maternal estrogen and progesterone was measured at the time of the starting day of progesterone (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy.; The OCP-LD begins in 2 to 3 days of the last menstrual cycle and then 500 μgr/d GnRH-a will received on day 17 for fourteen days. Then in 2-3 days of the next menstrual cycle, GnRH-a reduced to 200 μgr/d dose. the patients will receive 6 mg oral that will be continued for 14 days and during this time endometrium thickness evaluated by vaginal ultrasonography. If endometrial thickness is estimated ≥7mm, intramuscularly progesterone 100 mg/d will be started. After the onset of progesterone (days 17 to 18 cycles) frozen embryos transferred. In patients 35 days after embryo transfer and observation of gestational sac with heart beat (6 weeks of pregnancy) by ultrasound, exogenous estrogen will discontinued while progesterone will remain daily use until twelfth week of pregnancy. The levels of maternal estrogen and progesterone was measured at the time of the starting day of progesterone (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy.
Other intervention name(s): estradiol till 12 gestational weeks; estradiol till 6 gestational weeks
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Saw palmetto extract; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ongoing pregnancy rate; Estrogen; Frozen embryo transfer; Luteal phase support