Effects of Intramural Fibroids on IVF Outcome

Infertility, Female Clinical Trial

Official title:

Effects of Intramural Fibroids That do Not Distort the Uterine Cavity on IVF Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03904355
• Other study ID #: 54
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 2022

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +201005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Assisted Reproduction
• Infertility
• Infertility, Female

Intervention

Drug:
• Gonadotropins
Gonadotropin stimulation of follicular growth
• human chorionic gonadotropin
HCG triggering of ovulation

Procedure:
• Ovum pick up
34 to 36 hours after oocyte retrieval
• Embryo transfer
Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	appearance of one or more intrauterine gestational sac	4 weeks after embryo transfer