The Impact of Myomectomy on IVF Outcomes

NCT05932082 | Not Yet Recruiting

• 1 other identifier: MIO study
• Study Type: interventional
• Target: 792
• Locations: 0 countries
• Sites: N/A

Brief Summary

In 2% to 3% infertility women, myoma is the only factor relevant to their infertility. However, the effects of intramural myoma on fertility are controversial. For infertile women with intramural myoma (types IV, V, VI of FIGO system) of 4 to 6 cm diameter, it is not clear whether myomectomy could improve pregnancy outcomes, especially in women undergoing ART. Besides, rigorous clinical research is needed to explore the changes and relevant biomarkers of endometrial receptivity through multi-omics study in patients undergoing myomectomy and ART treatment. Method Intervention and follow-up: (1) For the control group, evaluation protocols such as salpingography and/or laparoscopic tubal fluxation should be implemented to identify disorders such as hydrosalpinx. (2) Imaging evaluation: all pelvic MRI were performed. Other options such as transvaginal ultrasound are not excluded, but won't replace MRI. Enhanced MRI or DWI may be considered, but are not always required. (3) Surgical intervention: laparoscopic myomectomy is preferred, and abdominal myomectomy is also acceptable. (4) IVF treatment: the IVF regimen should include detailed records of the downregulation plan, number of cycles, frozen or fresh blastocysts. Study endpoints (1) Primary study endpoint: Live birth rate after IVF. (2) Secondary study endpoints: Clinical pregnancy rate after IVF; Cumulative pregnancy rate after IVF; Biochemical pregnancy rate after IVF; Sustained pregnancy rate after IVF (≥20 weeks); Miscarriage rate after IVF; Cycles of IVF; Pregnancy-related complications; Perinatal maternal and neonatal complications. (3) Exploratory endpoints: The correlation between imaging index and assisted reproductive outcomes, including endometrial thickness, uterine volume, type of endometrial echo, uterine contraction; endometrial vascular index (VI), flow index (FI), tubular flow index (VFI); uterine artery pulsation index (PI), uterine artery resistance index (RI), systolic/diastolic blood pressure of uterine artery (S/D). The correlation between endometrial receptivity and assisted reproductive outcomes is analyzed based on transcriptomics, metabolomics, methylation and proteomics in samples from peripheral blood, endometrial biopsy, endometrial exfoliated cells, cervical exfoliated cells and myoma.

Conditions

Myoma;Uterus; IVF; Surgery

Outcome Measures

Primary Outcomes (1)

• Number of participants with live birth after IVF within one year

  Live birth rate after IVF in infertility patients with intramural myoma (types IV, V, VI) with a diameter of 4-6cm receiving or not receiving myomectomy.

  one year after IVF

Secondary Outcomes (8)

• Number of participants with of clinical pregnancy after IVF within one year

  one year after IVF

• Number of participants with cumulative pregnancy after IVF within one year

  one year after IVF

• Number of participants with Biochemical pregnancy rate after IVF

  one year after IVF

• Number of participants with sustained pregnancy rate after IVF (≥20 weeks)

  at least 20 weeks after IVF

• Number of participants with miscarriage after IVF

  one year after IVF

Study Arms (2)

myomectomy group

EXPERIMENTAL

The study group received IVF after myomectomy.

Procedure: myomectomy or not

control group

PLACEBO COMPARATOR

The control group was directed to IVF after the routine evaluation, probably including diagnostic laparoscopy.

Procedure: myomectomy or not

Interventions

myomectomy or not PROCEDURE

The study group receive myomectomy, while the control group don't receive myomectomy.

control group; myomectomy group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female aged between 20-40 years old.
• Primary or secondary infertility consisting of following factors rather than uterine factors: male factors, ovulation disorders, fallopian tube factors, endometriosis, other non-uterine factors including infertility with unexplained reason.
• Myoma: FIGO type 4-6 discovered by MRI with the maximum diameter surgically targeted between 4-6cm; Single myoma, or multiple myomas with non-surgically targeted intramural or subserous myoma(s) \< 2cm in maximum diameter.
• Justifying the IVF criteria and willing to undergo IVF.

You may not qualify if:

• Complicated with infertility factors of uterine factors or diseases, including adenomyosis, endometrial adhesion, endometritis, submucous myoma. However, resectable endometrial polyps need not be excluded.
• Complicated with malignancies or borderline tumors of the reproductive tract
• Complicated with other malignancies not been treated or still being treated.
• Complicated with active pelvic inflammatory disease.
• Previously receiving cytotoxic therapy or abdominal-abdominal chemoradiotherapy.
• Previous uterine body surgery, including but not limited to: myomectomy, resection for adenomyosis lesions, uterine artery embolization, uterine tumor coagulation (high energy focused ultrasound or electrocoagulation, hysteroscopically myomectomy. However, diagnostic hysteroscopy, diagnostic curettage and polypectomy need not be excluded.
• No willing to undergo IVF.
• Unable to be followed-up.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Myofibroma

Interventions

Uterine Myomectomy; Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Orphan Nuclear Receptors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cytoplasmic and Nuclear

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: July 6, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 4, 2023

Record last verified: 2023-08