Effects of Intramural Fibroids on IVF Outcome
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedAugust 31, 2021
August 1, 2021
2.9 years
March 31, 2019
August 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate
appearance of one or more intrauterine gestational sac
4 weeks after embryo transfer
Study Arms (2)
Fiboroid group
ACTIVE COMPARATORWomen with intramural myoma no reaching the cavity
Non fibroid group
ACTIVE COMPARATORWomen without myomas
Interventions
Gonadotropin stimulation of follicular growth
HCG triggering of ovulation
Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
Eligibility Criteria
You may qualify if:
- age younger than 40 years
- FSH) less than 10 IU/L
- serum prolactin level normal
- uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy medical school
Cairo, 12151, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged, MD
Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 31, 2019
First Posted
April 5, 2019
Study Start
May 1, 2019
Primary Completion
April 1, 2022
Study Completion
May 1, 2022
Last Updated
August 31, 2021
Record last verified: 2021-08