The Value of Myomectomy in Women With Intramural Myoma Before IVF.
Primary Purpose
Fibroid Uterus, IVF
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Open myomectomy
Gonadotropins
Human chorionic gonadotropin
Ovum pick up
Embryo transfer
Sponsored by
About this trial
This is an interventional treatment trial for Fibroid Uterus
Eligibility Criteria
Inclusion Criteria:
• age younger than 40 years
- FSH) less than 10 IU/L
- serum prolactin level normal
- uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography
Exclusion Criteria:
- abnormal endocrine function (e.g. abnormal thyroid or adrenal function)
- ovarian cysts,
- hydrosalpinx
- endometrial polyps
- male partner with azoospermia
- ICSI performed for preimplantation genetic diagnosis.
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Myomectomy group
Conservative group
Arm Description
women with intramural myoma not reaching endometrial cavity will undergo open myomectomy followed by ovarian stimulation for in vitro fertilization 6 months after the operation
women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization
Outcomes
Primary Outcome Measures
clinical pregnancy rate
appearance of one or more intrauterine gestational sac by transvaginal ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03904368
Brief Title
The Value of Myomectomy in Women With Intramural Myoma Before IVF.
Official Title
The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
Detailed Description
Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),
, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroid Uterus, IVF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myomectomy group
Arm Type
Active Comparator
Arm Description
women with intramural myoma not reaching endometrial cavity will undergo open myomectomy followed by ovarian stimulation for in vitro fertilization 6 months after the operation
Arm Title
Conservative group
Arm Type
Active Comparator
Arm Description
women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization
Intervention Type
Procedure
Intervention Name(s)
Open myomectomy
Intervention Description
laparotomy then enucleation of the myoma followed by closure of the myometrial cavity
Intervention Type
Drug
Intervention Name(s)
Gonadotropins
Other Intervention Name(s)
Controlled Ovarian stimulation
Intervention Description
Gonadotropin stimulation of follicular growth
Intervention Type
Drug
Intervention Name(s)
Human chorionic gonadotropin
Other Intervention Name(s)
Ovulation triggering
Intervention Description
HCG triggering of ovulation
Intervention Type
Procedure
Intervention Name(s)
Ovum pick up
Intervention Description
34 to 36 hours after HCG triggering
Intervention Type
Procedure
Intervention Name(s)
Embryo transfer
Intervention Description
Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
appearance of one or more intrauterine gestational sac by transvaginal ultrasound
Time Frame
4 weeks after embryo transfer
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• age younger than 40 years
FSH) less than 10 IU/L
serum prolactin level normal
uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography
Exclusion Criteria:
abnormal endocrine function (e.g. abnormal thyroid or adrenal function)
ovarian cysts,
hydrosalpinx
endometrial polyps
male partner with azoospermia
ICSI performed for preimplantation genetic diagnosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+201005227404
Email
prof.ahmedmaged@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Value of Myomectomy in Women With Intramural Myoma Before IVF.
We'll reach out to this number within 24 hrs