Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Frozen Embryo Transfer on Cycle Outcomes
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study is designed as a pilot study with 150 patients in each group. Data
      collection form will be filled by the researcher who does not know the type of intervention
      in each group. Data analysis will be done through descriptive and perceptive statistical
      methods by using SPSS software version 20 for windows
    

Detailed description: 
      This randomized double blinded clinical trial is conducted to evaluate the effect of
      intrauterine injection of human chorionic gonadotropin (hCG) before frozen embryo transfer
      (ET). The study protocol is approved by the Ethics Committee (Institutional Review Board) of
      Royan institute. The study is performed according to the Declaration of Helsinki for medical
      research. All participants provide informed consent after explaining the purpose of the
      study. All the patients with primary infertility who have only one fresh implantation failure
      and undergoing frozen embryo transfer cycles are enrolled. In all patients, endometrial
      preparation is performed by hormonal replacement method. In this way, endometrial preparation
      is started from the second or third day of menstrual cycle with daily administration of 6 mg
      oral estradiol valerate (Estraval®, Aburaihan CO, Tehran, Iran) for 8 days. After 8 days of
      estradiol administration, if favourable thickness of endometrium (≥ 8 mm) is confirmed by
      ultrasound, estradiol valerate is continued with the same dose and 50 mg progesterone
      (Progestin®, Aburaihan Pharmaceutical. Co., Tehran, Iran) intramuscularly is administered for
      3 days and then embryos are transferred. Otherwise the dosage of estradiol is increased to 8
      mg/day until the favourable thickness of endometrium be achieved. In the Embryo transfer day,
      the eligible patients are randomized using sealed opaque envelopes into three groups. In all
      study groups, the patient is put in the lithotomy position, and the cervix is visualized
      using Cusco's speculum. The cervical mucous is wiped out using a sterile piece of gauze, and
      then the mucous is partially removed by gentle suction with a 1-mL syringe. Embryo transfer
      is performed using a soft catheter (Labotec, Gottingen Germany). After the catheter is passed
      the internal cervical os; in group A (experimental group) 40 μL of tissue culture medium
      (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA,
      Switzerland) is injected intrauterine. In group B (the placebo group) only 40 μL of tissue
      culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine. In both groups,
      approximately 7 minutes after injection, the embryos are loaded into another ET catheter and
      are transferred into the uterine cavity. In group C (the control group), the ET is done
      without the intrauterine hCG injection. The ET procedure is performed just like in the other
      two groups.

      According to the patients' age, up to 3 frozen-thawed Embryos are thawed and transferred at
      cleavage stage. Hormone therapy is continued until pregnancy test (2 weeks after ET) is
      performed and in case of positive pregnancy, administration of estradiol valerate and
      progesterone continued by 10 and 12 weeks of gestation. Chemical pregnancy is defined by a
      rising hCG level in serum without the detection of a gestational sac. Clinical pregnancy is
      diagnosed by the presence of a gestational sac with fetal heart in vaginal ultrasonography.
      The miscarriage rate is defined as the loss of pregnancy before 20 weeks' gestational age.
    

Intervention name(s): intrauterine injection of uhCG; Placebo; control
Intervention type(s): Drug; Drug; Other
Intervention description(s): 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine, approximately 7 minutes before embryo transfer.; only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.; the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment