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Evaluation of human chorionic gonadotropin (HCG) addition during secretary phase in frozen-thawed embryo transfer cycles

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History
# Registration date Revision Id
3 2021-03-16, 1399/12/26 175403
2 2021-03-04, 1399/12/14 174364
1 2011-09-18, 1390/06/27 6862
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  • General information

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    سن بیشتر از 30 ؛شاخص توده بدني بيشتر از 30 ؛سابقه بيماري آندوكرين؛ بيماران با اندومتریوز شدید
    سن بیشتر از 38 ؛شاخص توده بدني بيشتر از 30 ؛سابقه بيماري آندوكرين؛ بيماران با اندومتریوز شدید

Protocol summary

Study aim
The aim of our study is to assess the advantage of HCG injection in secretory phase plus estrogen and progesterone to transfer cryopreserved-thawed embryos
Design
Primary outcome chemical pregnancy that is evaluated 2 weeks after embryo transfer.
Settings and conduct
This randomized clinical trial was conducted at the Yazd Research and Clinical Center for Infertility.This study was a randomized clinical trial. Infertile women who were candidates for frozen-thawed embryo transfers entered the study and were divided into two groups, HCG and control. The endometrial preparation method was similar in both groups.
Participants/Inclusion and exclusion criteria
All women have failed previous in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), and they have cryopreserved embryos transfer.Women older than 38 years, those with a body mass index (BMI) >30 kg/m2, history of endocrine disorders, and severe endometriosis were excluded from the study.
Intervention groups
In case group, HCG is injected 5000 IU in the first day of progesterone injection and in the embryo transfer time.
Main outcome variables
Primary outcome includes chemical pregnancy that is evaluated 2 weeks after embryo transfer

General information

Reason for update
up date clinical trial base on the latest changes in methods and enters results
Acronym
IRCT registration information
IRCT registration number: IRCT201107266420N4
Registration date: 2011-09-18, 1390/06/27
Registration timing: retrospective

Last update: 2021-03-16, 1399/12/26
Update count: 2
Registration date
2011-09-18, 1390/06/27
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid sadoughi university of medical sciences
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2010-12-30, 1389/10/09
Actual recruitment start date
2009-01-01, 1387/10/12
Actual recruitment end date
2010-12-30, 1389/10/09
Trial completion date
2011-06-30, 1390/04/09
Scientific title
Evaluation of human chorionic gonadotropin (HCG) addition during secretary phase in frozen-thawed embryo transfer cycles
Public title
Comparison of two protocols for transfer of the frozen embryos
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: History of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) fail; cryopreservation of excess embryos
Exclusion criteria:
age >38 years; BMI>30; history of endocrine disorder; severe endometriosis.
Age
From 18 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
Actual sample size reached: 130
Randomization (investigator's opinion)
Randomized
Randomization description
randomization by table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd reserch and clinical center for infertility
Street address
Booali street
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
928

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N99
ICD-10 code description
Postprocedural disorders of genitourinary system, not elsewhere classified

Primary outcomes

1

Description
chemical pregnancy
Timepoint
2 weeks
Method of measurement
serum BHCG

Secondary outcomes

1

Description
clinical sonography
Timepoint
2 weeks
Method of measurement
sonography

Intervention groups

1

Description
Intervention: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age. HCG 5000 IU is injected in the first day of progesterone injection and in the day of embryo transfer.
Category
Treatment - Drugs

2

Description
Control: all women receive estradiol valerate 6 mg PO per day from the second day of menstrual cycle. Endometrial thickness is assessing by using vaginal ultrasonography since 13th day of cycle. Progesterone 100mg is injected when endomethrial thickness reaches to 8 mm. Estradiol and progesterone consumption are continued until 10th weeks of gestational age.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd reserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
eftekhar@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd reaserch and clinical center for infertility
Full name of responsible person
Dr.Abbas Aflatoonian
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd reaserch and clinical center for infertility
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
Yazd research center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd reserarch and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Maryam Eftekhar
Position
Assisted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Avenue, Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participant data sets are to be shared
When the data will become available and for how long
2 months after the result publication
To whom data/document is available
A journal in which the results are published
Under which criteria data/document could be used
Submission of an official application via the agent that is legally in charge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.
Comments

Trial results

Please tick if results have been published
Yes
Summary result posting date
2021-03-08, 1399/12/18
Table of baseline comparison

Basic patient characteristics in the two groups

Variables HCG group Mean (SD) Control group Mean (SD) P value
Age (Years) 28.47 ± 4.14 28.84 ± 3.71 0.549
Duration of infertility (Years) 6.58 ± 2.9 6.09 ± 2.74 0.368
Basal FSH (IU/L) 5.15 ± 1.66 5.60 ± 1.72 0.135
BMI (kg/m2) 23.67 ± 2.43 23.86 ± 2.3 0.661
Etiology of infertility
Ovulatory , n (%) 13 (20) 13 (20) 0.201
Tubal, n (%) 9 (13.8) 10 (15.4)
Unexplained, n (%) 0 (0.0) 4 (3.1)
Mixed, n (%) 42 (64.6) 35 (53.8)
Male, n (%) 1 (1.5) 4 (3.1)
Total, n (%) 63 (100) 65 (100)
Participant flow diagram
Table of variable outcomes' results

ART outcome in both groups

​

Variables HCG group Control group P Value
Implantation rate (%) 21.02 17.44 0.488
Chemical pregnancy rate, n (%) 27 (41.5) 25 (38.5) 0.429
Clinical pregnancy rate, n (%) 22 (30.8) 20 (30.8.7) 0.426
Ongoing pregnancy rate, n (%) 20 (30.8) 18 (27.7) 0.424
Miscarriage rate, n (%) 7 (25.9) 7 (28.0.4) 0.556
Endometrial thickness (mm) 8.83±1.6 9.08±1.2 0.528
Table of adverse events
First publication date
2012-12-30, 1391/10/10
Abstract of published paper
Abstract Background: Human chorionic gonadotropin (HCG), one of the initial embryonic signals, is probably a major regulator of the embryo-endometrial relationship. This study aims to assess the advantage of HCG supplementation during the secretory phase of hormonally prepared cycles for the transfer of cryopreserved-thawed embryos. Materials and Methods: This study was a randomized clinical trial. Infertile women who were candidates for frozen-thawed embryo transfers entered the study and were divided into two groups, HCG and control. The endometrial preparation method was similar in both groups: all women received estradiol valerate (6 mg) po per day from the second day of the menstrual cycle and progesterone in oil (100 mg) intramuscular (I.M.) when the endometrial thickness reached 8 mm. Estradiol and progesterone were continued until the tenth week of gestation. In the HCG group, patients received an HCG 5000 IU injection on the first day of progesterone administration and the day of embryo transfer. Results: In this study, 130 couples participated: 65 in the HCG group and 65 in the control group. There was no statistically significant difference between groups regarding basic characteristics. Implantation rate, chemical pregnancy, clinical pregnancy, ongoing pregnancy, and abortion rates were similar in both groups. Conclusion: Although HCG has some advantages in assisted reproductive technology (ART) cycles, our study did not show any benefit of HCG supplementation during the secretory phase of frozen cycles (Registration Number: IRCT201107266420N4). Keywords: ART, Implantation, Frozen Embryo, HCG
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