Fibroid, Infertility
Conditions
Brief summary
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.
Interventions
PROCEDUREMyomectomy
Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 33 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage rate | 12 weeks gestational age | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies |
Countries
Egypt
Contacts
Primary ContactWaleed El-refaie, Dr
Outcome results
None listed