IRCT | Investigating the effect of intrauterine injection of human chorionic gonadotropin (hCG) on pregnancy outcomes in the transfer of fresh embryos in cycles related to assisted reproductive technology (ART)

Protocol summary

Study aim: The effect of intrauterine injection of hCG on pregnancy outcomes in the transfer of fresh embryos
Design: A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 158 patients. Random Allocation Software (RAS) is used for randomization.
Settings and conduct: Referred to the Shariati Hospital in Tehran in 2023; selection of 158 patients based on inclusion and exclusion criteria; randomization into two intervention and control groups by Random Allocation Software; blinding of patients
Participants/Inclusion and exclusion criteria: Inclusion: Aged 20 to 39 years old; embryos with A and B quality and fresh embryo transfer. Exclusion: Transfer of frozen embryo, age more than 40 years, male infertility, history of myomectomy, presence of hydrosalpinx, presence of fibroids with pressure effect on endometrium and endometriosis.
Intervention groups: Intervention group: On the day of transfer of a fresh embryo, injection of 500 units of hCG into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours, and daily injection of one progesterone ampoule for two weeks, checking serum beta-hCG level two weeks after the initial injection of hCG, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test. Control group: On the day of transfer of a fresh embryo, injection of 500 units of hCG into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours, and a daily injection of one progesterone ampoule for two weeks, checking serum beta-hCG level two weeks after the initial injection of hCG, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test.
Main outcome variables: Embryo implantation rate; clinical pregnancy rate; abortion rate MR; ongoing pregnancy rate (OPR )

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20230803059016N1

Registration date: 2023-08-21, 1402/05/30

Registration timing: prospective

Last update: 2023-08-21, 1402/05/30

Update count: 0
Registration date: 2023-08-21, 1402/05/30

Registrant information: Name

bahareh ghahroudizadeh abyaneh

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 8863 3039

Email address

drghahroudi@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-08-27, 1402/06/05
Expected recruitment end date: 2024-01-21, 1402/11/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Investigating the effect of intrauterine injection of human chorionic gonadotropin (hCG) on pregnancy outcomes in the transfer of fresh embryos in cycles related to assisted reproductive technology (ART)

Public title: Investigating the effect of intrauterine injection of human chorionic gonadotropin (hCG) on pregnancy outcomes in the transfer of fresh embryos in cycles related to assisted reproductive technology (ART)
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age 20 to 39 years old Embryos with A and B quality and fresh embryo transfer

Exclusion criteria:

Transfer of frozen embryo Male infertility History of myomectomy Presence of hydrosalpinx Presence of fibroids with pressure effect on endometrium and endometriosis. Age more than 40 years
Age: From 20 years old to 39 years old
Gender: Female

Phase

3

Groups that have been masked

Participant

Sample size

Target sample size: 158

Randomization (investigator's opinion)

Randomized

Randomization description

In this study, 158 patients will be randomly divided into two intervention groups (79 patients, HCG injection) and a placebo group (79 patients, standard treatment) by assigning three-digit codes by Random Allocation Software (RAS). Allocation concealment is used for concealment. This is done using opaque sealed envelopes in a random sequence (numbered, sealed, opaque envelopes). In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lids of the envelopes are glued and put in the box. At the time of registration of the participants, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be determined.

Blinding (investigator's opinion)

Single blinded

Blinding description

The blinding of this study will be single-blind and the patients will not be informed about the placement of individuals in the study groups.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Tehran University of Medical Sciences

Street address

6th floor of Research and Technology Deputy, Central Organization of the University, corner of Quds St, Keshavarz Blvd., Tehran

City

Tehran

Province

Tehran

Postal code

1411713135
Approval date: 2023-06-26, 1402/04/05
Ethics committee reference number: IR.TUMS.SHARIATI.REC.1402.052

Health conditions studied

1

Description of health condition studied: Pregnancy
ICD-10 code: Pregnancy
ICD-10 code description: O00-O08

Primary outcomes

1

Description: Embryo implantation rate
Timepoint: Before and after the intervention
Method of measurement: Vaginal ultrasound

Secondary outcomes

1

Description: Clinical pregnancy rate
Timepoint: Before and after the intervention
Method of measurement: Vaginal ultrasound

2

Description: Abortion rate MR
Timepoint: Before and after the intervention
Method of measurement: Vaginal ultrasound

3

Description: Ongoing pregnancy rate (OPR )
Timepoint: Before and after the intervention
Method of measurement: Vaginal ultrasound

Intervention groups

1

Description: Intervention group: After the completion of puncture, on the day of transfer of a fresh embryo with A-B cleavage stage, injection of 500 units of hCG (volume 0.1 cc, manufactured by Aburihan company) into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours (manufactured by Aburihan company) for 2 weeks, daily injection of one progesterone ampoule for 2 weeks (manufactured by Aburihan company), checking serum beta-hCG level two weeks after the initial injection of hCG to evaluate the positive or negative pregnancy, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test (4 weeks after the initial hCG injection).
Category: Treatment - Drugs

2

Description: Control group: After the completion of puncture, on the day of transfer of a fresh embryo with A-B cleavage stage, injection of 500 units of hCG (volume 0.1 cc, manufactured by Aburihan company) into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours (manufactured by Aburihan company) for 2 weeks, daily injection of one progesterone ampoule for 2 weeks (manufactured by Aburihan company), checking serum beta-hCG level two weeks after the initial injection of hCG to evaluate the positive or negative pregnancy, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test (4 weeks after the initial the peripheral solution).
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Shariati hospital

Full name of responsible person

Sedigheh Hosseinimousa

Street address

Shariati hospital, in front of the Faculty of Economics, North Kargar St., Jalal Al-Ahmed Street, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8490 1000

Email

sedighehoseinimosa@gmail.com

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Akbar Fotouhi

Street address

6th floor of Research and Technology Deputy, Central Organization of the University, corner of Quds St, Keshavarz Blvd., Tehran

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8163 3685

Email

vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tehran University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Behareh Ghahroudizadeh Abianeh

Position

Obstetrics and Gynecology Resident

Latest degree

Medical doctor

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Shariati hospital, in front of the Faculty of Economics, North Kargar St., Jalal Al-Ahmed Street, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8490 1000

Email

drghahroudi@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Sedigheh Hosseinimousa

Position

Assistant Professor

Latest degree

Specialist

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Shariati hospital, in front of the Faculty of Economics, North Kargar St., Jalal Al-Ahmed Street, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8490 1000

Email

sedighehoseinimosa@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Behareh Ghahroudizadeh Abianeh

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Shariati hospital, in front of the Faculty of Economics, North Kargar St., Jalal Al-Ahmed Street, Tehran, Iran

City

Tehran

Province

Tehran

Postal code

1411713135

Phone

+98 21 8490 1000

Email

drghahroudi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: The person's information will be confidential and the results will be as collective statistics.
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Not applicable
Title and more details about the data/document: This clinical trial will be a research article and its, results report and statistical analysis will be published to be used by therapists and researchers.
When the data will become available and for how long: If the journal has requested access to the data at any time, the data will be provided.
To whom data/document is available: Journal Editor and Reviewers
Under which criteria data/document could be used: Sometimes for re-analysis or for use in meta-analysis studies
From where data/document is obtainable: Project manager
What processes are involved for a request to access data/document: Mail to sedighehoseinimosa@gmail.com
Comments

Investigating the effect of intrauterine injection of human chorionic gonadotropin (hCG) on pregnancy outcomes in the transfer of fresh embryos in cycles related to assisted reproductive technology (ART)