Condition category
Pregnancy and Childbirth
Date applied
17/09/2014
Date assigned
27/10/2014
Last edited
06/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical mucus is a thick gelatinous substance that is discharged at various times during a menstrual cycle of a woman. The nature of this mucus is key in indicating the fertility of the woman at that point and thereby the ease of getting pregnant. In this study, we want to find out if removing the cervical mucus before performing intrauterine insemination (to medically assist getting pregnant) improves pregnancy outcomes in patients with unexplained infertility.

Who can participate?
Couples with unexplained infertility.

What does the study involve?
Participants will be randomly allocated to one of two groups. In participants allocated to the first group, cervical mucus will be removed before the intrauterine insemination procedure. Women allocated to the second group will not have their cervical mucus removed. The rates of pregnancy will be compared to find out if this works well.

What are the possible benefits and risks of participating?
Participants may benefit from an improved chance of pregnancy. There will not be any risks.

Where is the study run from?
1. Menoufiya University Hospital (Egypt)
2. Al-Hayat National Hospital, Kingdom of Saudi Arabia (KSA)

When is the study starting and how long is it expected to run for?
November 2014 to August 2016.

Who is funding the study?
1. Menoufia University (Egypt)
2. Hayat National Hospital (Kingdom of Saudi Arabia)

Who is the main contact?
Dr Mohamed Maher
mohamaher2015@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohammad Maher

ORCID ID

http://orcid.org/0000-0002-7332-5215

Contact details

Khamis Mushyat
Khamis Mushyat
101
Saudi Arabia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5

Study information

Scientific title

Cervical mucus removal prior to intrauterine insemination: can it improve pregnancy rates in women with unexplained infertility?

Acronym

Study hypothesis

The aim of this study is to detect whether the removal of cervical mucus prior to IUI can improve pregnancy outcomes in subfertile patients with unexplained infertility.

Ethics approval

1. Menoufia University ethical board (Egypt), 24/08/2014
2. Al-Hayat National Hospital ethical board (Saudi Arabia), 24/08/2014

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cervical mucus removal

Intervention

Patients will be randomized into two groups:
Group A: cervical mucus removal group
Group B: non-cervical mucus removal group, where only the external cervical os will be cleaned

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Clinical pregnancy rate (defined as ultrasound evidence of pregnancy or products of conception identified by histopathological examination) per patient at 2 weeks following IUI

Secondary outcome measures

N/A

Overall trial start date

01/10/2014

Overall trial end date

01/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 35 years or less
2. Body mass index (BMI) 30 kg/m2 or less
3. Diagnosis of unexplained infertility. The diagnosis of unexplained infertility was made according to the following points: normal semen analysis based on World Health Organization criteria (11), a preliminary transvaginal scan (TVS) on Day 2 of the cycle is normal with no detected ovarian pathology, normal (<10 IU/ml) follicular stimulating hormone (FSH) and luteinizing hormone (LH) measured on Day 2 of the cycle, normal serum prolactin level, normal thyroid function, midluteal serum progesterone levels >10 mg/dL, normal uterine cavity on hysterosalpingography or hysteroscopy, and patent tubes of normal appearance on hysterosalpingography and/or laparoscopy.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

At a study power of 80% with an á = 0.05, the total required cycles will be 714

Participant exclusion criteria

1. Women aged over 35
2. Hypogonadotrophic hypogonadism
3. Diminished ovarian reserve (basal FSH level >10 IU/ ml)
4. Presence of resistant ovarian cyst (>20 mm for >1 month)

Recruitment start date

29/10/2014

Recruitment end date

01/12/2016

Locations

Countries of recruitment

Egypt, Saudi Arabia

Trial participating centre

Menoufiya University Hospital
Shebin Elkom
101
Egypt

Trial participating centre

Al-Hayat National Hospital
Umm Sarar
Khamis Mushait
62461
Saudi Arabia

Sponsor information

Organisation

Menoufiya University Hospital (Egypt)

Sponsor details

Shebin Elkom
Shebin Elkom
101
Egypt

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Menoufia University (Egypt)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Hayat National Hospital (Saudia Arabia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 06/04/2016 the following changes were made to the trial record: 1. The recruitment end date was changed from 30/06/2016 to 01/12/2016. 2. The overall trial end date was changed from 31/08/2016 to 01/03/2017. On 14/12/2015 the following changes were made to the trial record: 1. The recruitment end date was changed from 31/03/2016 to 30/06/2016. 2. The overall trial end date was changed from 31/03/2016 to 31/08/2016. On 19/08/2015 the overall trial end date was changed from 30/09/2015 to 31/03/2016.