Objectives: endometriosis is a common condition that affects 10–15% of all women women during the reproductive years. Endometriosis is a major cause of infertility and may be present with no symptoms. In vitro fertilization (IVF) offers the highest chance of pregnancy for subfertile women with endometriosis. The aim of our study is to evaluate the reproductive outcomes of frozen-thawed embryo transfers (ET) cycles compared to fresh embryo transfer cycles, in women with endometriosis. Design: in this randomized controlled pilot study a total of 60 infertile women with endometriosis who will be referred to Royan Institute will be recruited. Setting and conduct: all subjects underwent conventional controlled ovarian stimulation using a ultra-long protocol. After puncture the patients will be divided in to two groups of study and control. In the study group embryos will be frozen for 2 months. Gonadotropin also is used for 2 months in order to prepare the endometrium. Then hormonal replacement therapy will be performed and followed by frozen-thawed embryo transfer. In control group, the fresh embryos will be transferred. Participants including major eligibility criteria: women with well-known predisposing factors for implantation failure such as thrombophilia, underlying immune conditions, uterine malformation (i.e. didelphys, septate, bicornuate or hypoplastic uterus); parental chromosomal abnormalities; severe male factor infertility; cancelled cycles which did not result in embryo transfers and women with frozen embryos in which their cycles had been canceled due to thin endometrial thickness. Intervention: The women will be randomly divided into two groups of frozen-thawed embryo transfer and fresh embryo transfer. Main outcome measures: Clinical pregnancy rate outcome will be compared between 2 groups. To confirm the pregnancy, the patients will be tested for serum β-hCG, 14 days after embryo transfer. Vaginal sonography will be done 2 weeks after the positive result of pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608171141N21
Registration date:2016-08-26, 1395/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-26, 1395/06/05
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
Expected recruitment start date
2014-01-30, 1392/11/10
Expected recruitment end date
2015-08-01, 1394/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing pregnancy rate between fresh and frozen embryo transfer cycles in women with endometriosis: a pilot Study
Public title
Comparison of pregnancy rate between fresh and frozen embryo transfer cycles in women with endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infertile patients with endometriosis; age ≤ 35 years; at least one endometrioma diagnosed by sonography or confirmed by laparoscopy; history of one failed in vitro fertilization failure (IVF).
Exclusion criteria: women with well-known predisposing factors for implantation failure such as thrombophilia, underlying immune conditions, uterine malformation (i.e. didelphys, septate, bicornuate or hypoplastic uterus); parental chromosomal abnormalities; severe male factor infertility; cancelled cycles which did not result in embryo transfers; women with frozen embryos in which their cycles had been canceled due to thin endometrial thickness.
Age
To 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
2012-09-25, 1391/07/04
Ethics committee reference number
EC/91/1085
Health conditions studied
1
Description of health condition studied
Endometriosis of ovary
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
4-6 weeks after embryos transfer (ET)
Method of measurement
Vaginal sonography
Secondary outcomes
1
Description
Implantation rate
Timepoint
4-6 weeks after embryos transfer (ET)
Method of measurement
Vaginal sonography
2
Description
Ongoing pregnancy rate
Timepoint
Pregnancy after 12 weeks of gestation
Method of measurement
Vaginal sonography
3
Description
Miscarriage rate
Timepoint
Abortion before 12 weeks of gestation
Method of measurement
Vaginal sonography
Intervention groups
1
Description
Intervention/ Control:
In the intervention group، embryos will be frozen for 2 months. Gonadotropin also is used for 2 months in order to prepare the endometrium. Then hormonal replacement therapy will be performed and followed by frozen-thawed embryo transfer.
Category
Treatment - Other
2
Description
Intervention/ Control:
In control group, the fresh embryos will be transferred.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Nadia Jahangiri
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
Nadia Jahangiri
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
100
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
Nadia Jahangiri
Position
MS of midwifery / principal investigator
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 2645
Fax
Email
tmadani@royaninstitute.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Tahereh Madani
Position
Gynecologist
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 2645
Fax
Email
tmadani@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Nadia Jahangiri
Position
MS of midwifery / principal investigator
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 2645
Fax
Email
tmadani@royaninstitute.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)