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

Primary Purpose

Infertility, Fibroid

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Myomectomy

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 33 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

Obstetrics and Gynecology Department in Mansoura University HospitalRecruiting
Obstetrics and Gynecology Department in Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Myomectomy

Conservative management

Arm Description

Women will be subjected to laparotomy to remove the myomas

Women will not be subjected to surgery (conservative management)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Miscarriage rate

Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Full Information

NCT ID

NCT03143114

First Posted

May 4, 2017

Last Updated

August 23, 2020

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT03143114

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

June 15, 2021 (Anticipated)

Study Completion Date

June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Fibroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Myomectomy

Arm Type

Experimental

Arm Description

Women will be subjected to laparotomy to remove the myomas

Arm Title

Conservative management

Arm Type

No Intervention

Arm Description

Women will not be subjected to surgery (conservative management)

Intervention Type

Procedure

Intervention Name(s)

Myomectomy

Intervention Description

Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Description

Time Frame

6-8 weeks gestational age

Secondary Outcome Measure Information:

Title

Miscarriage rate

Description

Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies

Time Frame

12 weeks gestational age

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

33 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Waleed El-refaie, Dr

Phone

+201224515318

wrefaie@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Waleed El-refaie, Dr

Organizational Affiliation

Port Said University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Khaled Samir, Dr

Organizational Affiliation

Mansoura University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mahmoud M Awad, Dr

Organizational Affiliation

Mansoura University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamed S Abdelhafez, Dr

Organizational Affiliation

Mansoura University

Official's Role

Study Chair

Facility Information:

Facility Name

Obstetrics and Gynecology Department in Mansoura University Hospital

City

Mansourah

State/Province

Dakahlia

ZIP/Postal Code

35111

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed S Abdelhafez, Dr

Facility Name

Obstetrics and Gynecology Department in Mansoura University

City

Port Said

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Waleed El-refaie, Dr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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