Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
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

Trial website

Contact information



Primary contact

Dr Mohammad Maher


Contact details

Khamis Mushyat
Khamis Mushyat
Saudi Arabia

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Cervical mucus removal


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



Drug names

Primary outcome measure

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


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

Egypt, Saudi Arabia

Trial participating centre

Menoufiya University Hospital
Shebin Elkom

Trial participating centre

Al-Hayat National Hospital
Umm Sarar
Khamis Mushait
Saudi Arabia

Sponsor information


Menoufiya University Hospital (Egypt)

Sponsor details

Shebin Elkom
Shebin Elkom

Sponsor type




Funder type

Hospital/treatment centre

Funder name

Menoufia University (Egypt)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Hayat National Hospital (Saudia Arabia)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data


Basic results (scientific)

Publication list

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.