Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility

Infertility Clinical Trial

Official title:

Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02539290
• Other study ID #: 2015-1146
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2015
• Last updated: March 2, 2017
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: March 2017
• Source: Centre Hospitalier Universitaire de Québec, CHU de Québec
• Contact: Sarah Maheux, MD-MSc
• Phone: 1-418-525-4444
• Email: sarah.maheux.lacroix[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.

Description:

In vitro fertilisation is the only current reasonable treatment for unexplained infertility. Uterine flushing, associated with a five-fold increase in pregnancy when performed preovulatory, has been proposed as a new alternative. This treatment could flush out debris or alter inflammatory factors preventing fertilisation and implantation. The objective of this study is to assess the efficacy of pre-ovulatory uterine flushing with physiological saline for the treatment of unexplained infertility. This study is a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least one year. The day of their luteinizing hormone surge, 192 participants will be randomised in two equal groups to either receive 20 millilitres of physiological saline by an intra-uterine catheter or 10 millilitres of saline intravaginally. Investigators will assess relative risk of live birth (primary outcome), as well as pregnancy over one cycle of treatment. Side effects, complications, and acceptability of the intervention will be reported.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

Inclusion Criteria:

• Primary or secondary infertility =12 months.

• Diagnosis of unexplained infertility =36 months:

• Anti-Mullerian hormone =0.4 ng/mL and/or follicle-stimulating hormone =13 IU/L in early follicular phase;

• regular cycle of 25-35 days,

• positive ovulation tests, and/or

• luteal phase serum progesterone =25mmol/L in a natural cycle;

• normal semen analysis;

• normal uterine cavity;

• patent tubes.

• Negative genitourinary test for gonorrhoea and chlamydia =12 months.

Exclusion Criteria:

• Body mass index =35 kg/m2.

• Ongoing pregnancy.

Related Conditions & MeSH terms

• Flushing
• Infertility
• Unexplained Infertility

Intervention

Behavioral:
• Detection of ovulation
Detecting the luteinizing hormone surge using test sticks in a urine sample

Procedure:
• Uterine flushing
Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge
• Vaginal flushing
Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge

Behavioral:
• Sexual intercourse
Sexual intercourse within 12 hours after intervention

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Quebec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with a live birth resulting from one cycle of treatment	Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data.	10 months after randomisation
Secondary	Proportion of participants with a pregnancy resulting from one cycle of treatment	Proportion of participants with a positive urinary or serum pregnancy test, gestational sac on ultrasound or histological evidence of trophoblastic tissue resulting from one cycle of treatment based on questionnaire and medical data.	One month after randomisation
Secondary	Adverse effects	Number of participants with treatment-related pain, vagal symptoms, nausea, vomiting, temperature, pelvic infection	One month after randomisation
Secondary	Proportion of participants who find the intervention acceptable	Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable.	One month after randomisation