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Trial record 37 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Embryo Transfer on Pregnancy Outcomes in Frozen Embryo Transfer Cycles.

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ClinicalTrials.gov Identifier: NCT02825108
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Brief Summary:
The present study is designed as a pilot study with 50 patients in each group. Data collection form will be filled by the researcher who does not know the type of intervention in each group

Condition or disease Intervention/treatment Phase
Infertility Drug: Intra uterine injection of tissue culture medium containing HCG+ET Drug: Intra uterine injection of tissue culture medium +ET Procedure: ET Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation the Effect of Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Frozen Embryo Transfer on Implantation and Clinical Pregnancy Rates Per Cycle , Phase 3 Randomized Double Blinded Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
The patients who receive 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.
Drug: Intra uterine injection of tissue culture medium containing HCG+ET
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.

Placebo Comparator: placebo group
The patients who receive only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.
Drug: Intra uterine injection of tissue culture medium +ET
) only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.

control group
The patients for whom the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups
Procedure: ET
the embryo transfer ( ET) is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.




Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 6 weeks ]
    Evaluation of Implantation rate 6 weeks after embryo transfer.


Secondary Outcome Measures :
  1. Pregnancy loss [ Time Frame: 12 weeks ]
    Evaluation of pregnancy loss under 12 weeks of gestational age.

  2. Early miscarriage rate [ Time Frame: 12 weeks ]
    Evaluation of Early miscarriage rate under 12 weeks of gestational age.

  3. Late miscarriage rate [ Time Frame: 20 weeks ]
    Evaluation of late miscarriage rate under 20 weeks of gestational age.



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Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with history of one fresh embryo transfer failure
  2. Patients with Primary infertility
  3. Patients with at least one embryo with excellent quality

Exclusion Criteria:

  1. Female age over 40 years old
  2. Severe male factor (Azoospermia)
  3. Endometriosis diagnosis and the presence of hydrosalpinges
  4. Uterine factor ( polyps, myoma and previous myomectomy, …)
  5. Patients with polycystic ovarian syndrome diagnosis
  6. Cases with pre-implantation genetic diagnosis (PGD)indication
  7. Cases with difficult embryo transfer or use of Tenaculum
  8. Patients with repeated implantation failures and repeated miscarriages.
  9. Female smokers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825108


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Tahere Madani, MD Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Study Director: Maryam Hafezi, MD Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Principal Investigator: Arezoo Arabipour, M.S.c Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

Additional Information:
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02825108     History of Changes
Other Study ID Numbers: Royan-Emb-025
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Royan Institute:
human chorionic gonadotropin (hCG), implantation rate intrauterine hCG clinical pregnancy rate frozen embryo transfer cycles
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs