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

Not Applicable

• Conditions: Infertility; Fibroid
• Interventions: Procedure: Myomectomy

• Registration Number: NCT03143114
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Study Start: 2017-05-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-23
• Last Update Posted: 2020-08-26
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myomectomy	Myomectomy	Women will be subjected to laparotomy to remove the myomas

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Miscarriage rate	12 weeks gestational age	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Trial Locations

Locations (2)

Obstetrics and Gynecology Department in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt

Obstetrics and Gynecology Department in Mansoura University; 🇪🇬 Port Said, Egypt