Improving success rate of embryo transfer in women with primary or secondary infertility
Design
Double blinded placebo controled randomized clinical trial, parallel groups, randomization by permuted block with 4 &6 block size using "ralloc" module of stata 14 mp software, phase 2 trial on 98 patients.
Settings and conduct
Trial conducted in Akbarabadi hospital IVF center, patients and care providers were blinded. 3 weeks after intervention, transvaginal ultrasound was performed to assess primary outcome.
Participants/Inclusion and exclusion criteria
Inclusion : women aged 18 -40 with primary or secondary imfertility,FET or ET embryo transfer, good quality embryo, three embryo of 2 days age.
Exclusion: blood pressure less than 100/60 mmHg, BMI more than 38kg/m2, abnormal uterine cavity, nifedipine contraindication, history of recurrent abortion or implantation failure
Intervention groups
Included patients were administered 10 mg oral nifedipine 30 min before embryo transfer.
Control group recieved placebo pill(with same shape to nifedipine) 30 min before embryo transfer
Main outcome variables
Clinical Pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201129049532N1
Registration date:2021-11-21, 1400/08/30
Registration timing:retrospective
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
Solmaz Hedayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2297 5465
Email address
solmaz.hedayat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-16, 1398/12/26
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
2020-03-16, 1398/12/26
Actual recruitment end date
2020-06-14, 1399/03/25
Trial completion date
2021-03-14, 1399/12/24
Scientific title
Evaluation of nifedipine administration on embyro transfer success rate, a Randomized Clinical Trial
Public title
Evaluation of nifedipine administration on embyro transfer success rate, a Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-40 with primary or secondary infertility
fresh or frozen embryo transfer
good embryo quality(based on defined criteria)
transfer of 3 embryo of two days age
Exclusion criteria:
Blood pressure less than 100/60mmHg
Body mass index > 38 kg/m2
Abnormal uterine cavity(congenital or acquired)
Nifedipine contraindications(history of severe allergic reaction, porphyria, severe heart failure)
Recurrent implantation failure
History of recurrent abortion
Age
From 18 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
98
Actual sample size reached:
98
Randomization (investigator's opinion)
Randomized
Randomization description
One to one permuted block randomization with 4-6 block size. No stratification.
Using Stata 14 software (ralloc module)
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinded with enveloped pocket containing allocation groups (A & B). Patients also will be blinded of administered drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Iranuniversity of medical sciences
Street address
Ethics committee, Faculty of medicine, Iran university of medical science, hemmat hw, tehran, iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.IUMS.FMD.REC.1398.556
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical Pregnancy
Timepoint
Before intervention and 3 weeks after intervention
Method of measurement
Transvaginal ultrasound and serum Bhcg
Secondary outcomes
1
Description
Live birth, multiple gestation, abortion
Timepoint
3 weeks after intervention, 9 months after intervention if primaryboutcome occured
Method of measurement
Transvaginal ultrasound, successful delivery
Intervention groups
1
Description
Intervention group: 18 - 40 year-old women with primary or secondary infertility, candidate for embryo transfer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi hospital IVF center
Full name of responsible person
Solmaz Hedayat MD
Street address
Akbarabadi hospital IVF center, Molavi st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
Solmaz.hedayat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Solmaz hedayat MD
Street address
Iran University of medical sciences, Hemmat hw, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Solmaz.hedayat@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?