Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.

Detailed Description
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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.

Official Title
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Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial

Conditions
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Infertility, Fibroid

Intervention / Treatment
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* Procedure: Myomectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 33 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myomectomy<br>Women will be subjected to laparotomy to remove the myomas | Procedure: Myomectomy<br>* Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision<br>|
| No Intervention: Conservative management<br>Women will not be subjected to surgery (conservative management) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6-8 weeks gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage rate | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies | 12 weeks gestational age |