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

NCT03904368 | Unknown DMC

• 1 other identifier: 55
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibroid Uterus; IVF

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  appearance of one or more intrauterine gestational sac by transvaginal ultrasound

  4 weeks after embryo transfer

Study Arms (2)

Myomectomy group

ACTIVE COMPARATOR

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

Procedure: Open myomectomy; Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Ovum pick up; Procedure: Embryo transfer

Conservative group

ACTIVE COMPARATOR

women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization

Drug: Gonadotropins; Drug: Human chorionic gonadotropin; Procedure: Ovum pick up; Procedure: Embryo transfer

Interventions

Open myomectomy PROCEDURE

laparotomy then enucleation of the myoma followed by closure of the myometrial cavity

Myomectomy group

Gonadotropins DRUG

Gonadotropin stimulation of follicular growth

Also known as: Controlled Ovarian stimulation

Conservative group; Myomectomy group

Human chorionic gonadotropin DRUG

HCG triggering of ovulation

Also known as: Ovulation triggering

Conservative group; Myomectomy group

Ovum pick up PROCEDURE

34 to 36 hours after HCG triggering

Conservative group; Myomectomy group

Embryo transfer PROCEDURE

Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

Conservative group; Myomectomy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Gonadotropins; Chorionic Gonadotropin; Embryo Transfer

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Ahmed Maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404; prof.ahmedmaged@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• 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: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

EG (1)