Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

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.

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Key information

Conditions

Embryo Implantation Genital Diseases Infertility Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royan Institute

Tehran, 16635-148, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles

Drug

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.

Other names: The effect of intramuscular injection of triple doses of human chorionic gonadotropin on embryo implantation

Primary outcomes

Rate of Implantation

Time frame: 6 weeks after embryo transfer

Implantation rate is the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Apr 22, 2021
Registry last updated: Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed