Effects of Glycodelin on women with implantation failure

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2016082120408N5
• Date of registration: 2016-10-05
• Prospective Registration: Yes
• Primary sponsor: Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
• Public title: Effects of Glycodelin on women with implantation failure
• 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.
• Date of first enrolment: 2016-11-30
• Target sample size: 40
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/18105
• Study type: interventional
• Study design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Other design features: Non-blinded, non-randomized pilot study.
• Phase: 2

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Marzieh Zamaniyan
• Affiliation: Infertility and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences,

• Name: Marzieh Zamaniyan
• Affiliation: Reproductive and Infertility Health Research Center, Shahid Beheshti University of Medical Sciences,

Key inclusion & exclusion criteria

Inclusion 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.
Exclusion criteria:

Age minimum: 20 years
Age maximum: 40 years
Gender: Female

Health Condition(s) or Problem(s) studied

Complication associated with artificial fertilization, unspecified

Noninflammatory disorders of female genital tract.
Complication associated with artificial fertilization, unspecified

Intervention(s)

Diagnosis

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.

Intervention 1: 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. Intervention 2: 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.

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.

Primary Outcome(s)

Serum glycodelin concentrations. Timepoint: On day 21-22 of menstrual cycles. Method of measurement: Laboratory kits.

Uterine flushing glycodelin concentrations. Timepoint: On day 21-22 of menstrual cycles. Method of measurement: Laboratory kits.

Source(s) of Monetary Support

Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Shahid Beheshti University of Medical Sciences.