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NCT04855383 Clinical Trial

Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

Embryo Implantation Clinical Trial

Official title:
The Effect of Intramuscular Injection of Triple Doses of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04855383
Other study ID # FET-HCG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date June 20, 2023

Study information
Verified date January 2024
Source Royan Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with frozen embryo transfer. The study population in frozen embryo transfer cycles receive three doses of human chorionic gonadotropin (HCG) to recognize the effectiveness of HCG on pregnancy outcomes in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Description:

During implantation, the biochemical crosstalk between the endometrium and embryo has a very important role. The endometrium secrets cytokines and growth factors that modulate embryonic differentiation and early development. One of the important molecular messages between the embryo and endometrium is human chorionic gonadotropin (HCG). HCG is expressed by the blastocyst before the implantation, while increasingly produced after implantation by the syncytiotrophoblast. In order to study the direct effect of HCG on the endometrium at implantation, this randomized, controlled clinical trial evaluated whether HCG supplementation would be beneficial for pregnancy outcomes of cryopreserved-thawed embryo transfer with estrogen/ progesterone replacement cycles at Royan Institute. Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 200 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 20, 2023
Est. primary completion date August 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Infertile women candidates for frozen embryo transfer - Age 20-40 years - Body Mass Index under than 30 Kg/m2 - Having at least three good quality embryos Exclusion Criteria: - Women with hematologic and autoimmune disorders - Couples with chromosomal and genetic abnormalities - Women with uterine anomalies - Women with uterine and ovaries surgical history - Women with endometriosis and adenomyosis - Women with hydrosalpinx - Women with uterine fibroids - Women with history of recurrent abortion or recurrent implantation failure - Severe male factor infertility (azoospermia) - Embryo donation cycle - Endometrial thickness less than 8 millimeter on the day of embryo transfer

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles
Patients receive 5,000 IU of human chorionic gonadotropin by intramuscular injection, 72 hours before embryo transfer, on the day of embryo transfer, and 72 hours after embryo transfer.

Locations
Country Name City State
Iran, Islamic Republic of Royan Institute Tehran

Sponsors (1)
Lead Sponsor Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Implantation Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period. 6 weeks after embryo transfer
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