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

M

Mansoura University

Status

Unknown

Conditions

Infertility
Fibroid

Treatments

Procedure: Myomectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 33 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Myomectomy
Experimental group
Description:
Women will be subjected to laparotomy to remove the myomas
Treatment:
Procedure: Myomectomy
Conservative management
No Intervention group
Description:
Women will not be subjected to surgery (conservative management)

Trial contacts and locations

2

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Central trial contact

Waleed El-refaie, Dr

Data sourced from clinicaltrials.gov

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