Comparison of pregnancy outcomes with the use of three types of progesterone in IVF cycles including subcutaneous Prolotex; Progesterone injections and Cyclogest suppositories to support the uterus.
Design
Three-group randomized clinical trial; Phase 4 is performed on 309 infertile women. Randomization is performed on one of three treatment groups with an equal number of patients using a table of random numbers from 1-309.
Settings and conduct
This study is performed as a clinical trial in the infertility center of Imam Khomeini Hospital in Tehran in 1998-99. Infertile IVF candidates are divided into three treatment groups with equal numbers of patients using a random number table and receive muscle progesterone, vaginal suppository, Cyclogest, and subcutaneous Prolotex, respectively.
Participants/Inclusion and exclusion criteria
Infertile women aged 18-42 years; BMI less than 30 and a history of less than three IVF cycles are included in the study. Cases of fibroids; Severe endometriosis; Hydrosalpinx and underlying diseases are among the cases not included in the study.
Intervention groups
To transfer the frozen fetus on the second day of menstruation, 2 mg estradiol valerate tablets are given three times a day for 9 days, and if there is an endometrium with a thickness of more than 7 mm in the first group, 100 mg of progesterone ampoule daily; In the second group, vaginal Cyclogest suppository 400 mg twice a day and in the third group, Subcutaneous Prolotex ampoules 25 mg daily; is prescribed up to 12 weeks of pregnancy.
Main outcome variables
Clinical pregnancy is the main outcome of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141217020351N12
Registration date:2020-12-06, 1399/09/16
Registration timing:registered_while_recruiting
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
Ensieh Shahrogh Tehraninejad
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
etehraninejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pregnancy results in IVF cycles with luteal phase support with progesterone, prolotex, and Cyclogest in infertility center.
Public title
Evaluation of pregnancy outcomes in IVF cycles with uterine support with progesterone, Prolotex, and Cyclogest in the infertility center.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women aged 18 to 42 years
BMI less than 30
Having less than three IVF cycles
FSH < 15 U/L
Estradiol less than 80 pg / ml
Having a normal uterine cavity on a recent hysteroscopy, sonohistogram, or hysterosalpingogram
Exclusion criteria:
Intramural fibroids deforming the uterine cavity
Endometriosis stage three and four
Hydrosalpinx
History of poor response to treatment
Spontaneous abortion
Adrenal disease
Thyroid disease
Thromboembolic diseases
Age
From 18 years old to 42 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
309
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed to one of three treatment groups with an equal number of patients using a random number table; In the order that we look from the top to the bottom of the table and patients enter the study randomly and in the order of the random number table; So that the researcher touches one of the numbers and then moves in the specified direction and records the numbers and assigns them to different groups. Patients in the first group, 1-100, the second group, 101-200, and the third group, 201-309, receive progesterone, Cyclogest, and Prolotex, respectively.
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
Vice -Chancellar in Research Affairs -Tehran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, sixth floor, Central University Organization, corner of Quds Street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
۵۳۷۶۱-۱۴۱۷۶
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1024
Health conditions studied
1
Description of health condition studied
Types of female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Clinical Pregnancy
Timepoint
Ten weeks after starting treatment
Method of measurement
Blood tests and ultrasound
Secondary outcomes
1
Description
Abortion
Timepoint
10 weeks after embryo transfer
Method of measurement
Blood tests and ultrasound
2
Description
Ectopic Pregnancy
Timepoint
5 weeks after embryo transfer
Method of measurement
Blood tests and ultrasound
Intervention groups
1
Description
Intervention group:In the first group; To transfer the frozen fetus on the second day of menstruation, 2 mg of Estradiol Valerate tablets are given three times a day for 9 days, and if there is an endometrium with a thickness of more than 7 mm, 100 mg of progesterone ampoule daily until 12 weeks of pregnancy is prescribed.
Category
Treatment - Drugs
2
Description
Intervention group:In the second group; To transfer the frozen fetus on the second day of menstruation, 2 mg Estradiol Valerate tablets are given three times a day for 9 days, and if there is an endometrium with a thickness of more than 7 mm, a Cyclogest suppository 400 mg twice a day for up to 12 weeks of Pregnancy is prescribed.
Category
Treatment - Drugs
3
Description
Intervention group:In the third group; To transfer the frozen fetus on the second day of menstruation, 2 mg Estradiol Valerate tablets are given three times a day for 9 days. If there is an endometrium with a thickness of more than 7 mm, Prolotex 25 mg daily, subcutaneously for up to 12 weeks of Pregnancy is prescribed.