Comparison of the effect of oral progesterone and vaginal progesterone on luteal phase support using available drugs in IVF/ICSI candidates
Design
160 participant are divided randomly in to two groups of 80 who are administered oral or vaginal progesterone as an luteal phase support. The randomization is performed using random allocation rule.
Settings and conduct
the study will be hold in IVF clinic in Ayatollah mousavi hospital. each participant is administered with either vaginal or oral progesterone as a luteal phase support and the pregnancy out come is compared between two group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. IVF/ICSI candidates
2. age between 18 to 40 years old
3. available informed written consent
exclusion criteria:
1. history of drug reaction to drugs used in this study
2. endometriosis
3. Partner azospermia
4. Uterine anatomical anomaly
5. endocrine or metabaolic disorder
6. 2 or more unsuccessful IVF or FET
7. repetitive spontaneous abortion
Intervention groups
Vaginal or oral progesterone is administered in two different groups as an luteal phase support
Main outcome variables
successful pregnancy
Unsuccessful pregnancy ( abortion or preterm labor)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211101052938N1
Registration date:2021-11-14, 1400/08/23
Registration timing:prospective
Last update:2021-11-14, 1400/08/23
Update count:1
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Nazli Ghamari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
nazlighamari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-02, 1400/09/11
Expected recruitment end date
2022-03-31, 1401/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral progesterone and vaginal progesterone on luteal phase support using available drugs in IVF/ICSI candidates
Public title
Comparison of the effect of oral progesterone and vaginal progesterone on luteal phase support
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
IVF/ICSI candidate with history of infertility
age between 18 to 40 years old
have an informed consent to participate in the study
Exclusion criteria:
drug reaction history to one of the drugs used in this study
endocrine or metabolic disorders
endometriosis
Azospermia of partner
uterine anatomic anomaly
history of 2 or more unsuccessful IVF or FET
history of repetitive spontaneous abortion
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
For randomized categorization of the participants we use random allocation rule. 160 participants are divided randomly in to two even groups of 80; case group and control group. The written name of participants are put in the accordant bowl randomly and without replacement and subsequent random sequence will be made.
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
Ethics committe of Zanjan university of medical sciences
Street address
Azadi Blv, Zanjan university of medical sciences, Postal code: 4515613191
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
Ir.Zums.REC.1400.346
Health conditions studied
1
Description of health condition studied
In vitro fertilization
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percent of successful pregnancy following in vitro fertilization
Timepoint
Evaluating the outcome of pregnancies at the end of the study
Method of measurement
Recording the successful and unsuccessful pregnancy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group 400 mg vaginal progesterone (Fertigest 400 mg vaginal of Aburaihan Pharmaceutical Co)is prescribed for luteal phase support.
Category
Treatment - Drugs
2
Description
Control group: In this group Dofamed 10 mg (Atipharmed Pharmaceutical Company) is prescribed orally three times a day for luteal phase support.