Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

NCT ID: NCT04855383

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-06-20

Brief 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.

Detailed 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.

Conditions

Embryo Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The group of frozen embryo transfer with intramuscular injection of human chorionic gonadotropin.

In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. 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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

The group of frozen embryo transfer without intramuscular injection of human chorionic gonadotropin.

In this group, endometrial preparation for embryo transfer will be through the standard protocol using a gonadotropin-releasing hormone agonist. Embryo transfer will be done without human chorionic gonadotropin intramuscular injection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Royan Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehri Mashayekhi, M.D.

Role: STUDY_DIRECTOR

Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.

Azar Yahyaei, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Female Infertility, ACECR, Tehran, Iran.

Locations

Royan Institute

Tehran, , Iran

Countries

Iran

Other Identifiers

FET-HCG

Identifier Type: -

Identifier Source: org_study_id