To evaluate the effect of the growth hormone on the uterine respectivity of the patients with recurrent implantation failure
Qualitative evaluation of the uterus after the intervention by help of vaginal sonography, two- dimensional and three-dimensional Doppler vaginal ultrasound
Design
single-blind randomized two-arm clinical trial study in two groups of growth hormone-receiving and non-growth-hormone patients in patients with recurrent implantation failure
Settings and conduct
In this prospective study which will be done by clinical trial, the patients with recurrent implantation failure were divided into an intervention group (receiving 8 units of the growth hormone from the beginning of the daily subcutaneous injection of estradiol valerate to the beginning of progesterone injection) and a control group through blocked randomization. It will be a single-blind trial for the researchers. The researchers responsible for data collection and those who assess outcomes will not have access to patients’ medical records and clinical report forms. They will simply collect patients’ outcomes based on the initial list for participation in the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women between the ages of 22 and 38, recurrent Implantation Failure between 3 to 6 times , BMI≤ 30
Exclusion criteria: Underlying disease such as: diabetes, Hypertension, Congenital uterine anomalies Endometrial adhesions , submucosal myomas
Intervention groups
The intervention group includes the patients with recurrent implantation failure who will receive the intervention of the growth hormone.
The control group includes the patients with recurrent implantation failure who will not receive the intervention of the growth hormone.
Main outcome variables
Clinical pregnancy by defining the observation of pregnancy sac on transvaginal ultrasound in the 5th week of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201003048912N1
Registration date:2020-12-21, 1399/10/01
Registration timing:registered_while_recruiting
Last update:2020-12-21, 1399/10/01
Update count:1
Registration date
2020-12-21, 1399/10/01
Registrant information
Name
Mina Ataei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
m.ataee@abz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of growth hormone on endometrial acceptance and increasing pregnancy success in women with recurrent implantation failure
Public title
The effect of growth hormone on endometrial acceptance and increasing pregnancy success in women with recurrent implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Grade A good fetal inclusion criteria, blastocysts with sufficient number, have a history of more than two previous failures despite good fetal transfer, no previous hormone growth cycle, no other interventions in this cycle, no donation cycle, no hormone contraindications, not having hydrosalpinx.
Exclusion criteria:
Age over 40 years, endometriosis, severe oligospermia, (morphology count <1%), patients with hydrosalpinx, kidney and liver diseases, diabetes and thyroid and autoimmune diseases and local allergic reactions and benign increase in intracranial pressure
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks with size 4 in www.sealedenvelope.com web site
Blinding (investigator's opinion)
Single blinded
Blinding description
The researchers responsible for data collection and those who assess outcomes will not have access to patients’ medical records and clinical report forms. They will simply collect patients’ outcomes based on the initial list for participation in the research. These people are not aware of the type of assignment of participants to the control and intervention group.
Placebo
Not used
Assignment
Other
Other design features
Evaluation of the effect of growth hormone injection on pregnancy outcomes in patients with recurrent implantation failure
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University Jihad Ibn Sina Infertility Center
Street address
Tehran, Shariati St., corner of Yakhchal St., No. 97, Jihad University, Ibn Sina Infertility Center
City
Tehran
Province
Tehran
Postal code
1941913114
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1399.005
Health conditions studied
1
Description of health condition studied
Patients with recurrent implantation failure
ICD-10 code
Spontaneou
ICD-10 code description
O03
Primary outcomes
1
Description
Pregnancy rate
Timepoint
Three months after taking the drug
Method of measurement
The number of patients with BHCG positive is divided by the number of patients who had fetus transfer
Secondary outcomes
1
Description
Endometrial acceptance
Timepoint
Three months after taking the drug
Method of measurement
Definition of chemical pregnancy: Patients with a positive pregnancy test
Intervention groups
1
Description
Intervention group: this study attempts to explore and assess 35 infertile women with further three recurrent implantation failures. This group will receive the growth hormone produced by CinnaGen Company for the frozen embryo transfer (FET). From the third day of menstruation, the oral estradiol valerate (6 mg/day) and subcutaneous injection of 8 units of the growth hormone will be prescribed. The injection of the growth hormone will be continued until the day on which progesterone is injected. Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial color Doppler sonography, endometrial thickness, endometrium, pulsatility index, resistance index, and left and right uterine artery are measured and the embryo is transferred then.
Category
Other
2
Description
Control group: This study seeks to explore and assess 35 infertile women with further three recurrent implantation failures. This group will not receive the growth hormone for the frozen embryo transfer (FET). From the third day of menstruation, the oral estradiol valerate (6 mg/day) will be prescribed. Five days prior to blastocyst embryo transfer, intramuscular injection of progesterone and the oral estradiol valerate (6 mg/day) will be prescribed. In the morning of the day of embryo transfer, the subendometrial color Doppler sonography, endometrial thickness, endometrium, pulsatility index, resistance index, and left and right uterine artery are measured and the embryo is transferred then.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Jihad University Research Institute, Ibn Sina Infertility Center
Full name of responsible person
Soheila Ansaripour
Street address
Shariati St., corner of Yakhchal St., No. 97, Jihad University, Ibn Sina Infertility Center