Intramuscular Injection of Human Chorionic Gonadotropin in Frozen Embryo Transfer Cycles

NCT04855383 | Completed DMC

• 1 other identifier: FET-HCG
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Embryo Implantation

Keywords

Human chorionic gonadotropin; frozen embryo transfer; infertility; assisted reproduction technology; estrogen/ progesterone replacement cycles

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

NO INTERVENTION

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.

Interventions

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.

Also known as: The effect of intramuscular injection of triple doses of human chorionic gonadotropin on embryo implantation

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

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, 16635-148, Iran

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Mehri Mashayekhi, M.D.

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

  STUDY DIRECTOR

• Azar Yahyaei, M.Sc.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: July 1, 2020
• Primary Completion: August 22, 2022
• Study Completion: June 20, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After the publication of the article
• Access Criteria: Available to the public. Scientific use by citing the source.

Locations

IR (1)