The Value of Myomectomy in Women With Intramural Myoma Before IVF.

IVF Clinical Trial

Official title:

The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03904368
• Other study ID #: 55
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +201005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 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

• Fibroid Uterus
• IVF
• Leiomyoma

Intervention

Procedure:
• Open myomectomy
laparotomy then enucleation of the myoma followed by closure of the myometrial cavity

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

Procedure:
• Ovum pick up
34 to 36 hours after HCG triggering
• 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 by transvaginal ultrasound	4 weeks after embryo transfer