Comparison of serum and uterine flushing Glycodelin concentrations in reproductive cycles among women with in vitro fertilization failure and fertile controls: A pilot Study.
Objectives: Glycodelin is an agent which regulates immunological factors activity. This is required in implantation window. The present study was conducted to compare glycodelin concentrations in blood and uterine flushing samples obtained from women with in vitro fertilization failure and fertile controls.
Study design: Twenty infertile women with in vitro fertilization failure and twenty fertile women in control group, phase 2, single center, non-blinded, non-randomized pilot study.
Setting and conducts: Women based on inclusion criteria will be divided in two groups. Patients and physicians, informed and aware of the intervention. Injection of normal saline into the uterus and examination the return uterine fluid about glycodelin concentrations will be done on day 21 to 22 of the menstrual cycle in both groups. At the same time, blood sampling will be taken for evaluation of serum glycodelin concentrations in both groups.
Inclusion criteria: Forty women aged 20 to 40 years, in vitro fertilization failure in half of them (at least 2 cycles of in vitro fertilization failure), lack of polyps or uterine fibroids. Exclusion criteria: Presence of uterine polyps or fibroids, history of hormone use in the past two months, active vaginal infection.
Intervention: Injection of normal saline into the uterus on day 21 to 22 of the menstrual cycle and examination the return uterine fluid about glycodelin concentrations. At the same time, blood sampling will be taken for evaluation of serum glycodelin concentrations in patients with in vitro fertilization failure and fertile control group.
Primary outcome: Glycodelin concentrations in serum and uterine flushing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082120408N5
Registration date:2016-10-05, 1395/07/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-05, 1395/07/14
Registrant information
Name
Robabeh Taheripanah
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
taheripanahf@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-11-30, 1395/09/10
Expected recruitment end date
2017-01-31, 1395/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of serum and uterine flushing Glycodelin concentrations in reproductive cycles among women with in vitro fertilization failure and fertile controls: A pilot Study.
Public title
Effects of Glycodelin on women with implantation failure
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Forty women aged 20 to 40 years; in vitro fertilization failure in half of them (at least 2 cycles of in vitro fertilization failure) ; lack of polyps or uterine fibroids. Exclusion criteria: Presence of uterine polyps or fibroids; history of hormone use in the past two months; active vaginal infection.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Non-blinded, non-randomized pilot study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences.
Street address
220 Plaque, Third floor, Shahid Beheshti University of Medical Sciences, Velenjak Ave, Chamran high way, Tehran
City
Tehran
Postal code
1393944176
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
102
Health conditions studied
1
Description of health condition studied
Noninflammatory disorders of female genital tract
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Serum glycodelin concentrations
Timepoint
On day 21-22 of menstrual cycles.
Method of measurement
Laboratory kits.
2
Description
Uterine flushing glycodelin concentrations
Timepoint
On day 21-22 of menstrual cycles
Method of measurement
Laboratory kits
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Injection of normal saline into the uterus on day 21 to 22 of the menstrual cycle (intrauterine insemination catheter, Cook Company, USA) and examine the uterine flushing and blood sampling for evaluation of glycodelin concentrations.
Category
Diagnosis
2
Description
Intervention 2: Injection of normal saline into the uterus on day 21 to 22 of the menstrual cycle (intrauterine insemination catheter, Cook Company, USA) and examine the uterine flushing and blood sampling for evaluation of glycodelin concentrations.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospitals
Full name of responsible person
Marzieh Zamaniyan
Street address
233 plaque, Third floor, IVF ward, Taleghani Hospital, Velenjak Ave, Chamran high way, Tehran
City
Tehran.
2
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Marzieh Zamaniyan
Street address
67 plaque, second floor, Obstetrics and Gynecology ward, Imam Hossein Hospital, Shahid madani Ave, Imam Hossein Square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Full name of responsible person
Zahra Sadeghzadeh
Street address
262 plaque, Third Floor, Sahid Beheshti University of Medical Sciences, Velenjak Ave, Chamran high way, Tehran
City
Tehran
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
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
Reproductive and Infertility Health Research Center, Shahid Beheshti University of Medical Sciences,
Full name of responsible person
Marzieh Zamaniyan
Position
Assistant professor, M.D.
Other areas of specialty/work
Street address
233 plaque, Third floor, IVF ward, Taleghani Hospital, Velenjak Ave, Chamran high way, Tehran
City
Tehran
Postal code
1393944176
Phone
+98 21 2271 2234
Fax
-
Email
marziehzamaniyan@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences,
Full name of responsible person
Marzieh Zamaniyan
Position
Assistant professor
Other areas of specialty/work
Street address
233 plaque, Third floor, IVF ward, Taleghani Hospital, Velenjak Ave, Chamran high way, Tehran
City
Tehran
Postal code
1393944176
Phone
+98 11 3336 5724
Fax
-
Email
marziehzamaniyan@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences,
Full name of responsible person
Marzieh Zamaniyan
Position
Assistant professor/M.D.
Other areas of specialty/work
Street address
233 plaque, Third floor, IVF ward, Taleghani Hospital, Velenjak Ave, Chamran high way, Tehran
City
Tehran
Postal code
1393944176
Phone
+98 21 3335 0670
Fax
-
Email
marziehzamaniyan@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)