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

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ClinicalTrials.gov Identifier: NCT03143114
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
WaleedAl Refaie, 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.

Condition or disease Intervention/treatment Phase
Infertility Fibroid Procedure: Myomectomy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Myomectomy
Women will be subjected to laparotomy to remove the myomas
Procedure: Myomectomy
Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision

No Intervention: Conservative management
Women will not be subjected to surgery (conservative management)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Miscarriage rate [ Time Frame: 12 weeks gestational age ]
    Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies



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Ages Eligible for Study:   20 Years to 33 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143114


Contacts
Contact: Waleed El-refaie, Dr +201224515318 wrefaie@yahoo.com

Locations
Egypt
Obstetrics and Gynecology Department in Mansoura University Hospital Recruiting
Mansourah, Dakahlia, Egypt, 35111
Contact: Mohamed S Abdelhafez, Dr         
Obstetrics and Gynecology Department in Mansoura University Recruiting
Port Said, Egypt
Contact: Waleed El-refaie, Dr         
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Waleed El-refaie, Dr Port Said University
Study Director: Mohamed S Abdelhafez, Dr Mansoura University

Responsible Party: WaleedAl Refaie, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT03143114     History of Changes
Other Study ID Numbers: WR3
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female