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Effects of Intramural Fibroids on IVF Outcome

Primary Purpose

Infertility, Female, Assisted Reproduction

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gonadotropins
human chorionic gonadotropin
Ovum pick up
Embryo transfer
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility, Female

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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 schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fiboroid group

Non fibroid group

Arm Description

Women with intramural myoma no reaching the cavity

Women without myomas

Outcomes

Primary Outcome Measures

clinical pregnancy rate
appearance of one or more intrauterine gestational sac

Secondary Outcome Measures

Full Information

First Posted
March 31, 2019
Last Updated
August 30, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03904355
Brief Title
Effects of Intramural Fibroids on IVF Outcome
Official Title
Effects of Intramural Fibroids That do Not Distort the Uterine Cavity on IVF Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
May 2022 (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
A cohort study involving 200 women candidate for IVF / ICSI cycles . 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
A cohort study involving 200 women candidate for IVF / ICSI cycles . 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
Infertility, Female, Assisted Reproduction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fiboroid group
Arm Type
Active Comparator
Arm Description
Women with intramural myoma no reaching the cavity
Arm Title
Non fibroid group
Arm Type
Active Comparator
Arm Description
Women without myomas
Intervention Type
Drug
Intervention Name(s)
Gonadotropins
Other Intervention Name(s)
Ovarian stimulation
Intervention Description
Gonadotropin stimulation of follicular growth
Intervention Type
Drug
Intervention Name(s)
human chorionic gonadotropin
Other Intervention Name(s)
Triggering of ovulation
Intervention Description
HCG triggering of ovulation
Intervention Type
Procedure
Intervention Name(s)
Ovum pick up
Intervention Description
34 to 36 hours after oocyte retrieval
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
Time Frame
4 weeks after embryo transfer

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Intramural Fibroids on IVF Outcome

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