IRCT | The randomized single-blinded clinical trial comparing growth hormone effect versus placebo on Improving the outcome of pregnancy in infertile patients.

Protocol summary

Study aim: Investigation the effect of GH injection on improving quality of follicle in poor ovarian responder.
Design: In this phase 3 three arms single- blinded trial, 105 infertile patients with poor ovarian response after signing inform consent assessing inclusion and exclusion criteria will recruit to study and randomly divided into three groups A, B &C. In intervention group A GH at the 8 cycle, in intervention group B GH in the early cycle and in intervention group C placebo injected until received 18 mm follicle, the oocyte quality will evaluated by embryologist after ova pick up .
Settings and conduct: The location of the study infertility ward in Dr Shariati Hospital. This is a single blind trial, and patients are not aware of the type of growth hormone or placebo.
Participants/Inclusion and exclusion criteria: Inclusioncriteria: Sign the informed consent form, Patients with poor ovarian response, (Having a maximum of 3 ovum after induction ovulation protocols,AFC less than 5, AMH less than 0.5 -1.1 ng/ml) Exclusion criteria: Women with FSH level more than 20 IU / L; women with diabetics melitus.
Intervention groups: In intervention group A continued with a Growth Hormone called Somatropine (2.5 mg) subcutaneously from the eighth day of the cycle, Growth Hormone injection in intervention group B from early cycle and In the intervention group C placebo (normal saline) is injected until reaching the follicle of more than 18 mm.
Main outcome variables: Main outcome measures include: The dose and frequency of injection of HMG, the number and quality of mature follicles, number and quality of eggs and the number of ovocytes obtained puncture, resulting embryo, the embryo transferring, clinical and laboratory fertility rate, abortion rate and live birth. rate. We expect that there is a significant difference in the control group between the investigation group.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20140818018842N14

Registration date: 2018-08-11, 1397/05/20

Registration timing: retrospective

Last update: 2018-08-11, 1397/05/20

Update count: 0
Registration date: 2018-08-11, 1397/05/20

Registrant information: Name

Leyla Sharifi Aliabadi

Name of organization / entity

Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic

Country

Iran (Islamic Republic of)

Phone

+98 21 8490 3691

Email address

ctu@sina.tums.ac.ir

Recruitment status: Recruitment complete
Funding source: Vice president of research Tehran University of Medical Science (TUMS).

Expected recruitment start date: 2016-04-20, 1395/02/01
Expected recruitment end date: 2017-08-23, 1396/06/01
Actual recruitment start date: 2016-04-20, 1395/02/01
Actual recruitment end date: 2017-09-11, 1396/06/20
Trial completion date: empty

Scientific title: The randomized single-blinded clinical trial comparing growth hormone effect versus placebo on Improving the outcome of pregnancy in infertile patients.

Public title: “Effect of treatment with growth hormone in infertility”
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Sign the informed consent form Patients with poor ovarian response based on criteria provided by the Union embryology and infertility Europe 2011. Strong history of poor ovarian response (Having a maximum of three ovum after inducing ovulation protocols) Low score ovarian reserve (AFC less than 7, AMH less than 0.5-1.1 ng/ml)

Exclusion criteria:

Women with high levels of FSH (more than 20 IU/L) Women with a history of infertility due to known non poor ovarian resonce Women with diabetes (type I or II)
Age: From 20 years old to 50 years old
Gender: Female

Phase

3

Groups that have been masked

Participant
Data analyser

Sample size

Target sample size: 105

Actual sample size reached: 105

Randomization (investigator's opinion)

Randomized

Randomization description

Patients are divided into 3 study groups by balanced block randomization. The list of randomized patients is made by a person not involved in the study and then the participants are randomly assigned into treatment groups.

Blinding (investigator's opinion)

Single blinded

Blinding description

Patients recruited into trial after signing inform consent and assessing inclusion and exclusion criteria, randomly assigned to three groups A, B and C by a person not involved in the study, according to randomization patients will received drug (growth hormone or placebo), in the same package based on the protocol, the physician knows what treatment has been used but data analyzer is blinded.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Tehran University Medical Sciences

Street address

Ethics Committee of Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran town.

City

Tehran

Province

Tehran

Postal code

1417653761
Approval date: 2016-12-07, 1395/09/17
Ethics committee reference number: IR.TUMS.MEDICINE.REC.1395.1186

Health conditions studied

1

Description of health condition studied: poor ovarian response
ICD-10 code: N97.0
ICD-10 code description: Female infertility associated with anovulation

Primary outcomes

1

Description: The follicle number obtained in the ART cycle.
Timepoint: Before starting treatment, on day eighth of a cycle, 36 hours after injecting HCG
Method of measurement: Trans vaginal ultrasonography

Secondary outcomes

1

Description: The number of metaphase II follicles achieved in the ART cycle.
Timepoint: According embryologist report at ovum puncture
Method of measurement: Count of meta-phase II follicles in embryologist ward by microscopic observation

2

Description: The number of quality embryos obtained from the ART cycle
Timepoint: Third and fifth day after fertilization in the laboratory
Method of measurement: Report embryologists based grading A, B, C.

3

Description: The number of positive pregnancy test
Timepoint: 14 days after embryo transfer
Method of measurement: BHCG over than 40 IU

4

Description: Successful clinical pregnancy
Timepoint: 6 to 8 weeks after embryo transfer
Method of measurement: Fetal Heart in Transvaginal ultrasonography

Intervention groups

1

Description: Intervention group 1: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and growth hormone(Somatropin, 2.5mg/day, subcutaneously)from the eight day of the cycle for about 5 days.
Category: Treatment - Drugs

2

Description: Intervention group 2: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and growth hormone (Somatropin, 0.1mg/day, subcutaneously) from the third day of the previous cycle for about 20 days.
Category: Treatment - Drugs

3

Description: Intervention group 3: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and placebo (Normal saline 1ml/day, subcutaneously, uniformed to Somatropin) from the eight day of the cycle for about 5 days.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Infertility Ward, Dr shariati Hospital

Full name of responsible person

Atefe Samaei

Street address

Infertility Ward, Dr shariati Hospital, North Kargar, Tehran Town.

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+98 21 84901

Fax

+98 21 8822 0050

Email

asamaei@razi.tums.ac.ir

Web page address

1

Sponsor: Name of organization / entity

Deputy of Research and Technology, Tehran University of Medical Sciences.

Full name of responsible person

Dr Mohammad ali Sahraeian

Street address

Tehran University of Medical Sciences, Qods Avenue, Keshavarz Boulevard.

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+98 21 8163 3619

Fax

+98 21 8163 3623

Email

rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Deputy of Research and Technology, 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

Atefe Samaei

Position

Assistant Obstetrics and Gynecology

Latest degree

Medical doctor

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Tehran University of Medical Science. Keshavarz Boulevard, North Kargar, Tehran Town.

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+98 21 84901

Fax

+98 21 8822 0050

Email

asamaei@razi.tums.ac.ir

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Atefeh Samaei

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Shariati Hospital, North Kargar Ave.

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+218 4901

Fax

+98 21 8800 4140

Email

asamaei@razi.tums.ac.ir

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Dr Shariati Hospital

Full name of responsible person

Atefeh Samaei

Position

Assistant Obstetrics and Gynecology

Latest degree

Medical doctor

Other areas of specialty/work

Gynecology and Obstetrics

Street address

Dr Shariati Hospital, North Kargar, Tehran Town.

City

Tehran

Province

Tehran

Postal code

1417653761

Phone

+98 21 84901

Fax

+98 21 8822 0050

Email

asamaei@razi.tums.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 data is published after being unidentified.
When the data will become available and for how long: starting 12 months after publication.
To whom data/document is available: available for people working in academic institution and people working in businesses can also apply to receive it.
Under which criteria data/document could be used: The requirements for submitting a request for access to data and documentation include: - Certificate from university and research institutes - Field is a researcher related subject. - The focus of the people working in the industry on the subject matter.
From where data/document is obtainable: Access to information by sending an email to the following address may: asamaei@razi.tums.ac.ir
What processes are involved for a request to access data/document: The receipt of the data after the submission of the documentation will be received up to a month after the submission of the request.
Comments

The randomized single-blinded clinical trial comparing growth hormone effect versus placebo on Improving the outcome of pregnancy in infertile patients.