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Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Frozen Embryo Transfer on Cycle Outcomes

Information source: Royan Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: intrauterine injection of uhCG (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Royan Institute

Official(s) and/or principal investigator(s):
Hamid Gourabi, PhD, Study Chair, Affiliation: Head of Royan Institute
Maryam Hafezi, MD, Study Director, Affiliation: Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Tahereh Madani, MD, Study Director, Affiliation: Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Arezoo Arabipour, MSC, Principal Investigator, Affiliation: Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

Overall contact:
Nasser Aghdami, MD,PhD, Phone: (+98)21235000, Ext: 516, Email: nasser.aghdami@royaninstitute.org

Summary

This study is a prospective double blind randomized controlled trial to investigate the effect of intrauterine injection of human chorionic gonadotropin injection (hCG) on outcomes of frozen embryo transfer cycles. The study population consisted of all infertile women who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Clinical Details

Official title: Evaluation the Effect of Intrauterine Injection of Human Chorionic Gonadotropin Injection (hCG) Before Frozen Embryo Transfer on Implantation, Clinical Pregnancy and Miscarriage Rates: Double Blind Randomized Clinical Trial ,Phase 3

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical pregnancy rate

Secondary outcome:

Ongoing pregnancy

miscarriage rate

Chemical pregnancy rate

Detailed description: This is a randomized, double blind; placebo-controlled clinical trial will be performed from October 2014 to October 2016 in Royan institute. The eligible patients who fulfilled the study criteria will be included in the trial. Study protocol and assays All the patients will have a complete history evaluation and physical examination by the attending gynecologist who is blinded to the study. The syringes with volume of 0. 5 ml from each group were prepared by fellowship student and injected blinded by the attending gynecologist. Endometrial preparation for frozen-thawed embryo transfer with pretreatment with gonadotropin-releasing hormone agonist will be performed for all of study population. After ultrasonography confirmed an endometrial thickness ≥8 mm and no evidence of preovulatory follicles,corpus luteum, or hyperechoic endometrium, progesterone in oil was administered i. m. at a dose of 100 mg. One to three embryos were transferred via the transcervical route 48 hours later. On the of embryo transfer, the patients will be randomly assigned to two study groups using a permuted-block randomization method. Those assigned to first study group will be received 500 IU (0. 5ml) of uhCG (Choriomon®, IBSA, Lugano, Switzerland) through intrauterine injection 10 minutes before Frozen ET (n=100), while the second group will be received intrauterine injection of normal saline (0. 5ml) 10 minutes before ET (n=100). All the patients will put in the lithotomy position and the cervix are visualized using a speculum. The cervical mucus will be then wiped out ET will be carried out using a malleable catheter (Cook Medical). The uhCG (500 IU) or normal saline is injected in the midpoint of endometrial cavity using the same catheter. Approximately 10 minutes after the intrauterine injection of uhCG or normal saline, the embryos are loaded into a new similar ET catheter and transferred. All the patients will be followed and the pregnancy test is requested 2 weeks after the ET. Pregnancy will be documented by transvaginal sonography, at 4 weeks of gestation after obtaining a positive pregnancy test. Main outcome measurements are implantation and clinical pregnancy rates. We also will be recorded the abortion rate, multiple pregnancy rate, and ongoing pregnancy rate (calculated by subtracting abortion from pregnancy rate). Clinical pregnancy is defined as the observation of gestation sac with fetal echoes and pulsations on transvaginal sonography at 4th-6th week. Multiple gestational sacs are counted as one clinical pregnancy. Chemical pregnancy is defined by a rising β-hCG level in serum without the detection of a gestational sac. The abortion rate is defined as the loss of pregnancy before 20 weeks of gestation. Loss of pregnancy after 20 weeks of gestation is defined as still birth.

Eligibility

Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Primary infertile women with previous history of one fresh IVF/ICSI cycle. 2. Age 20-40 years. 3. Patients who underwent Hormonal+GnRH-a preparation protocol for frozen embryo transfer Exclusion Criteria: 1. Oocyte or embryo donation cycles. 2. Uterine diseases or malformations. 3. The presence of hydrosalpinges. 4. Thyroid disorders and autoimmune disorders or endocrinopathies. 5. Tuberculosis. 6. Recurrent abortion history. 7. Severe endometriosis. 8. Severe male factor cases. 9. Body mass index (BMI) ≥ 30 kg/m2

Locations and Contacts

Nasser Aghdami, MD,PhD, Phone: (+98)21235000, Ext: 516, Email: nasser.aghdami@royaninstitute.org

Royan Institute, Tehran, Iran, Islamic Republic of; Recruiting
Nasser Aghdami, MD,PhD, Phone: (+98)2123562000, Ext: 516, Email: nasser.aghdami@royaninstitute.org
Leila Arab, MD, Phone: (+98)2123562000, Ext: 414, Email: Leara91@gmail.com
Maria Sadeghi, B.S.c, Sub-Investigator
Narges Bagher Lankarani, Ph.D, Sub-Investigator
Additional Information

Starting date: October 2014
Last updated: February 3, 2015

Page last updated: August 23, 2015

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