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 pregnancymiscarriage 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
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