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

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

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

Study Overview

• Status: Unknown
• Conditions: Infertility; Fibroid
• Intervention / Treatment: Procedure: Myomectomy

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
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Waleed El-refaie, Dr; Phone Number: +201224515318; Email: wrefaie@yahoo.com

Study Locations

• Egypt
  • Port Said, Egypt
    • Recruiting
    • Obstetrics and Gynecology Department in Mansoura University
    • Contact: Waleed El-refaie, Dr
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35111
      • Recruiting
      • Obstetrics and Gynecology Department in Mansoura University Hospital
      • Contact: Mohamed S Abdelhafez, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Waleed El-refaie, Dr, Port Said University; Study Director: Khaled Samir, Dr, Mansoura University; Study Director: Mahmoud M Awad, Dr, Mansoura University; Study Chair: Mohamed S Abdelhafez, Dr, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Anticipated): June 15, 2021
• Study Completion (Anticipated): June 15, 2021

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: WR3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No