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Subcutaneous progesterone (Prolutex) versus vaginal (Cyclogest) for luteal phase support in IVF/ICSI cycles: a randomized controlled clinical trial study phase 3

Protocol summary

Summary
This study is planned to evaluate the efficacy and tolerability of subcutaneous administration of progesterone compared with vaginal progesterone for luteal phase support in cycles IVF / ICSI in referring patients to the Royan Institute. A randomized controlled clinical trial is conducted during 1393 to 1394 in the Royan Institute. After ovum pick up, eligible women were randomly allocated into two groups (group A and B). luteal phase support is done in two ways: subcutaneous injection of progesterone (Prolutex) and vaginal suppository. In the Group A (n = 70), since ovum pick up day, a daily subcutaneous injections of progesterone (25 mg) (Prolutex®; IBSA Institut, SA Biochimique) will be used and in the Group B (n= 70), one vaginal suppository will be used (Cyclogest ®; Actavis, Barnstaple, UK), If pregnancy is occurred it continues until 10 weeks of pregnancy. Sixteen days after embryo transfer, as well as 6 and 10 weeks of pregnancy, possible side effects (gastrointestinal, skin, and local), pain and discomfort during use of the drugs will follow by the designed questionnaire and will be recorded. Side-effect, clinical pregnancy and abortion rates will be compared between two groups by appropriate statistical tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402191141N18
Registration date: 2015-02-19, 1393/11/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-02-19, 1393/11/30
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute and Shafayab gostar pharmaceutical company
Expected recruitment start date
2015-02-21, 1393/12/02
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Subcutaneous progesterone (Prolutex) versus vaginal (Cyclogest) for luteal phase support in IVF/ICSI cycles: a randomized controlled clinical trial study phase 3
Public title
Subcutaneous progesterone versus vaginal suppository for luteal phase support in assisted reproductive technology cycles in patients referred to Royan Institute
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Female age 19–39 years ; An written consent to participate in the study ;Body mass index (BMI ) <30 kg/m2 Exclusion Criteria: Severe male infertility (TESE, PESA) ; The uterine cause of infertility (uterine surgery history, cervical insufficiency, submucosal myoma or intramural fibroids ≥ 5 cm and multiple uterine polyps) ; Patients with poor ovarian response or patients with reduced ovarian reserve (FSH ≥ 15 IU/ml, AMH ≤ 1 ng/ml) ; Tubal factor was diagnosed as hydrosalpinx ; Moderate and severe endometriosis (stage3and 4) ; Cases of repeated implantation failure (RIF) and spontaneous abortions.
Age
From 19 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-01-13, 1393/10/23
Ethics committee reference number
1102/93/EC

Health conditions studied

1

Description of health condition studied
Other complications associated with artificial fertilization
ICD-10 code
N98
ICD-10 code description
Complications associated with artificial fertilization

Primary outcomes

1

Description
Clinical pregnancy rate
Timepoint
Evidence of pregnancy by clinical (fetal heartbeat) or ultrasound parameters (ultrasound visualization of a gestational sac, embryonic pole with heartbeat)after 7-6 weeks after embryos transfer
Method of measurement
Vaginal sonography

2

Description
Pain during drug use
Timepoint
The patient records pain during drug using based on visual scale from 0 to 10
Method of measurement
Visual analog scale

3

Description
Comfort and satisfaction of drug
Timepoint
The patient records comfort and satisfaction during drug using based on visual scale from 0 to 10
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Early Miscarriage rate
Timepoint
spontaneous loss of a pregnancy before 12 weeks
Method of measurement
Vaginal sonography

Intervention groups

1

Description
Intervention: Luteal phase support during ART treatment with subcutaneous injections of progesterone (Prolutex): since ovum pick up day, a daily subcutaneous injection of progesterone (25 mg) (Prolutex®; IBSA Institut, SA Biochimique) will be used and if pregnancy is occurred it continues until 10 weeks of pregnancy.
Category
Treatment - Drugs

2

Description
Control group : Luteal phase support during ART treatment using a vaginal suppository (Cyclogest) : Since ovum pick up day, one vaginal suppository every 12 hours will be used (Cyclogest ®; Actavis, Barnstaple, UK), If pregnancy is occurred it continues until 10 weeks of pregnancy.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Dr Moini
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Dr.Abdolhossein Shahverdi
Street address
: Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Shafayab Gostar company
Full name of responsible person
Elham Sahafi
Street address
275 number , after Modarres Bridge , beheshti Street.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shafayab Gostar company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Ashraf Moini
Position
Gynecologist / Professor
Other areas of specialty/work
Street address
: Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2640
Fax
Email
a_moini@royaninstitute.org
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Ashraf Moini
Position
Giynicologist / Professor
Other areas of specialty/work
Street address
: Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2640
Fax
Email
a_moini@royaninstitute.org
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Arezoo Arabipoor
Position
M.Sc of midywiferry
Other areas of specialty/work
Street address
: Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2356 2640
Fax
Email
arezoo.arabipoor@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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