InfertilityNCT03143114
Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women
A study testing Myomectomy in people with Infertility and Fibroid, run by Mansoura University at 2 sites in Egypt.
Trial summary
The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women. Read more about this study
- Who is it for?
- Ages 20 to 33 years, women only
- Conditions the study is for
- Infertility, Fibroid
- What is being tested?
- Myomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 May 2017to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 33 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertility for at least one year.
- Presence of intramural myoma.
- Absence of any other cause of infertility as revealed by basic infertility work up including laparoscopy.
Who cannot join
- Age is < 20 or > 33 years.
- Symptomatic fibroid causing pelviabdominal swelling.
- Presence of > 2 myomas.
- Presence of a coexisting another type of myoma other than intramural myoma (e.g. submucosal, subserosal, cervical or ligamentary myoma).
- Presence of any other cause of infertility.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Mohamed S Abdelhafez, Dr
- Recruiting
Obstetrics and Gynecology Department in Mansoura University
Port Said
Waleed El-refaie, Dr
About this study
Official title: Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial
The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.
Read the detailed description
All women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. Women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. Women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. Women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. Women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.
- Conditions
- Infertility, Fibroid
- Being tested
- Myomectomy
- Medical subject headings
- Infertility, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyomectomyProcedure or surgery
Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision
| Study group | Role | What they receive |
|---|---|---|
| Myomectomy | Experimental | Women will be subjected to laparotomy to remove the myomas Receives: Procedure: Myomectomy |
| Conservative management | No intervention | Women will not be subjected to surgery (conservative management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
Measured: 6-8 weeks gestational age
Secondary outcomes (1)
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Measured: 12 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start15 May 2017
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waleed El-refaie, Dr, Principal investigator, Port Said UniversityKhaled Samir, Dr, Study director, Mansoura UniversityMahmoud M Awad, Dr, Study director, Mansoura UniversityMohamed S Abdelhafez, Dr, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143114
- Sponsor's protocol ID
- WR3
- Status last verified
- Aug 2020
- First submitted
- 4 May 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03143114
- Acronym / sponsor ID
- WR3
- Conditions
- Infertility, Fibroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.
Detailed description
All women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. Women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. Women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. Women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. Women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myomectomy | Experimental | Procedure: MyomectomyWomen will be subjected to laparotomy to remove the myomas |
| Conservative management | No intervention | –Women will not be subjected to surgery (conservative management) |
Who may qualify
- Ages
- 20 to 33 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Infertility for at least one year.
- Presence of intramural myoma.
- Absence of any other cause of infertility as revealed by basic infertility work up including laparoscopy.
Key exclusion criteria (5 listed)
- Age is < 20 or > 33 years.
- Symptomatic fibroid causing pelviabdominal swelling.
- Presence of > 2 myomas.
- Presence of a coexisting another type of myoma other than intramural myoma (e.g. submucosal, subserosal, cervical or ligamentary myoma).
- Presence of any other cause of infertility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyomectomyLaparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision | Procedure or surgery | Myomectomy |
Primary outcome
Clinical pregnancy rate
Time frame: 6-8 weeks gestational age
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
1 secondary outcome
Miscarriage rate
Time frame: 12 weeks gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed El-refaie, Dr principal investigator
Port Said University
Khaled Samir, Dr study director
Mansoura University
Mahmoud M Awad, Dr study director
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myomectomy in people with Infertility and Fibroid, run by Mansoura University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waleed El-refaie, Dr (+201224515318, wrefaie@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 6-8 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.