About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not meeting all the inclusion criteria.
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.
Trial design
Parallel
Treatments tested in this trial
myomectomy or not
Procedure/SurgeryThe study group receive myomectomy, while the control group don't receive myomectomy.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Number of participants with of clinical pregnancy after IVF within one year
Clinical pregnancy rate after IVF in infertility patients with intramural myoma (types IV, V, VI) with a diameter of 4-6cm receiving or not receiving myomectomy.
Number of participants with cumulative pregnancy after IVF within one year
Cumulative pregnancy rate after IVF in infertility patients with intramural myoma (types IV, V, VI) with a diameter of 4-6cm receiving or not receiving myomectomy.
Number of participants with Biochemical pregnancy rate after IVF
Biochemical pregnancy rate after IVF in infertility patients with intramural myoma (types IV, V, VI) with a diameter of 4-6cm receiving or not receiving myomectomy.
Number of participants with sustained pregnancy rate after IVF (≥20 weeks)
Sustained pregnancy rate after IVF in infertility patients with intramural myoma (types IV, V, VI) with a diameter of 4-6cm receiving or not receiving myomectomy.
Locations
Sponsors and contacts
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