Determination of the effect of short-acting GnRh agonist on Outcome IVF in the FET cycle
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct
The study will be double-blind and the therapist and the statistician are not aware of the type of segmentation. In this study, patients who enter FET cycle were randomly divided into two groups of control and intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least two Grade A fetuses, absence of intrauterine anomaly such as adenomyosis and uterine fibroids, and uterine malformations and Clear endometrial mass, use of agonist protocol, absence of systemic diseases, vitamin D modification before initiation of ICSI.
Exclusion criteria: Endometrioma identified during FET
Intervention groups
Control group: In this group, we are administering 2-3 tablets daily of estrogen during the second day. 10 days later the patient is referred to the clinic and endometrial thickness is measured, If the endometrial thickness is above 8, the cycle will continue the same way and then progesterone is prescribed and the transfer is done.
Intervention group: Twenty-one Cinafact units a day from progesterone onset will be given to the patient from Mid luteal phase and continue the same way and then from the second day of the period we are given 2-3 tablets of estrogen, ten days later the patient returns to the clinic And the endometrial thickness is measured And then progesterone is prescribed and the transfer is done.
Main outcome variables
The effect of GnRh on endometrial readiness, implantation rate and clinical pregnancy outcomes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190916044781N1
Registration date:2019-10-13, 1398/07/21
Registration timing:retrospective
Last update:2019-10-13, 1398/07/21
Update count:0
Registration date
2019-10-13, 1398/07/21
Registrant information
Name
Farahnaz Zandi
Name of organization / entity
Sarem Infertility Fertility Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 0883
Email address
dr.zandi@saremhospital.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of GnRh Agonist short acting in IVF outcome improvement in FET cycles
Public title
Use of the GnRh Agonist to Improve Outcome IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least two embryos for transfer.
The embryo has been removed from the freeze after thawing and has grade A quality.
Absence of internal uterine anomalies such as adenomyosis and uterine fibroids and uterine malformations
Absence of clear endometrioma
Patients who used the agonist protocol in the ICSI cycle.
Absence of systemic diseases (such as collagen, vascular disease, chronic hypertension, diabetes: a well-known case of diabetes with a fasting FBS of over 126)
Vitamin D should be modified before starting ICSI.
Age range from 25 to 40 years.
Exclusion criteria:
Determine endometrioma during FET.
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
This study is an interventional type study (RCT) and it was designed to compare the effect of using short-acting GnRh agonist and not using it to improve IVF results in FET cycles.
Simple randomization will be done by double-blind blocking and both the therapist and the statistician are not aware of the type of divisions.
Patients are provided with informed consent forms after providing sufficient explanations about the study and it will be approved and signed by them. These patients will be emphasized and will be randomly divided into different treatment groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blind and the therapist and the statistician are not aware of the type of segmentation. Patients entering FET cycle were randomly divided into control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemat Highway next to MMilad, Tehran,Iran.
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.IUMS.REC.1397.985
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
2
Description of health condition studied
Endometriosis preparation for freezing embryo transfer
ICD-10 code
N98.9
ICD-10 code description
complication associated with artificial fertilization ,unspecified
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
Day 14 after transfer
Method of measurement
laboratory tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twenty-one Cinafact units a day from progesterone onset will be given to the patient from Mid luteal phase and continue the same way and then from the second day of the period we are given 2-3 tablets of estrogen, ten days later the patient returns to the clinic And the endometrial thickness is measured And then progesterone is prescribed and the transfer is done.
Category
Treatment - Drugs
2
Description
Control group: In this group, we are administering 2-3 tablets daily of estrogen during the second day. 10 days later the patient is referred to the clinic and endometrial thickness is measured, If the endometrial thickness is above 8, the cycle will continue the same way and then progesterone is prescribed and the transfer is done.