Management of unexplained infertility
| ISRCTN | ISRCTN87670645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87670645 |
| Secondary identifying numbers | 5 |
- Submission date
- 17/09/2014
- Registration date
- 27/10/2014
- Last edited
- 06/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Scientific
Khamis Mushyat
Khamis Mushyat
101
Saudi Arabia
 ORCID ID |
0000-0002-7332-5215 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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(s) | 1. Menoufia University ethical board (Egypt), 24/08/2014 2. Al-Hayat National Hospital ethical board (Saudi Arabia), 24/08/2014 |
| 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 |
| 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 | N/A |
| Overall study start date | 01/10/2014 |
| Overall study end date | 01/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | At a study power of 80% with an á = 0.05, the total required cycles will be 714 |
| 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 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
Study participating centres
101
Egypt
Khamis Mushait
62461
Saudi Arabia
Sponsor information
University/education
Shebin Elkom
Shebin Elkom
101
Egypt
"ROR" |
https://ror.org/03sq8r703 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
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.
