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

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

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.

Study Overview

• Status: Unknown
• Conditions: IVF; Fibroid Uterus
• Intervention / Treatment: Drug: Gonadotropins; Procedure: Embryo transfer; Procedure: Open myomectomy; Drug: Human chorionic gonadotropin; Procedure: Ovum pick up

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Myomectomy group; 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	Drug: Gonadotropins; Gonadotropin stimulation of follicular growth; Other Names: Controlled Ovarian stimulation; Procedure: Embryo transfer; Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval; Procedure: Open myomectomy; laparotomy then enucleation of the myoma followed by closure of the myometrial cavity; Drug: Human chorionic gonadotropin; HCG triggering of ovulation; Other Names: Ovulation triggering; Procedure: Ovum pick up; 34 to 36 hours after HCG triggering
Active Comparator: Conservative group; women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization	Drug: Gonadotropins; Gonadotropin stimulation of follicular growth; Other Names: Controlled Ovarian stimulation; Procedure: Embryo transfer; Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval; Drug: Human chorionic gonadotropin; HCG triggering of ovulation; Other Names: Ovulation triggering; Procedure: Ovum pick up; 34 to 36 hours after HCG triggering

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	appearance of one or more intrauterine gestational sac by transvaginal ultrasound	4 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 31, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Reproductive Control Agents; Chorionic Gonadotropin
• Other Study ID Numbers: 55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No