Clinical trial NCT01156181: Effect of Cervical Discharge Removal During ET on Pregnancy Rate
Official title: Effect of Cervical Discharge Removal Before Embryo Transfer on ICSI Cycle Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-07-02
Enrollment: 492
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even small differences in embryo transfer methods may affect pregnancy rates. There is an inconsistency about the effect of the removal of cervical discharge on embryo transfer outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase pregnancy rate, however the others could not find any significant effect about the removal of cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our study aimed to determine whether the cervical discharge removal has positive effect on pregnancy rate.

Detailed description: 492 Infertile women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos. All categories of female or male factors infertility except uterine factor infertility were eligible for participation in the study. Immediately prior to embryo transfer, women were randomly allocated to either treatment (cleaning the cervical canal) or control groups. In treatment group, excess mucus and debris were cleared from the cervical canal using a sterile cotton swabs. The cervical discharge was scored as mucosal, bloody, combination of mucosal and bloody, or infected. Control group had no cervical cleaning before embryo transfer. Then, the embryos were loaded into the transfer catheter by the embryologist and were deposited into the uterine cavity by one experience physician. The primary endpoint was clinical pregnancy. Fertilization, Implantation, abortion, and live birth rates were the other outcomes of interest or secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos and age fewer than 40

Exclusion Criteria:

* The patients with frozen-thawed embryo transfer cycle
* Those with oocyte donation cycle
* The women with uterine abnormality
* The women with submucosal and intramural myoma
* Who does not have good-quality embryos appropriate

Primary outcomes:
measure: Pregnancy rate
timeFrame: 9 months after recruiting
Secondary outcomes:
measure: Fertilization rate
timeFrame: 2 weeks
measure: Implantation rate
timeFrame: 1 month
measure: Miscarriage rate
timeFrame: 9 months
measure: Live birth rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Academic staff of Endocrinology and Female Infertility Department, Royan Institute, Tehran - Iran
name: Ashraf Moini Moini, MD
role: STUDY_CHAIR
affiliation: Investigator
name: Ladan Mohammadi yeganeh, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moini A, Kiani K, Bahmanabadi A, Akhoond M, Akhlaghi A. Improvement in pregnancy rate by removal of cervical discharge prior to embryo transfer in ICSI cycles: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):315-20. doi: 10.1111/j.1479-828X.2011.01318.x. Epub 2011 Jun 9.