An interventional study of Myomectomy in Infertility, In Vitro Fertilization (IVF) and Uterine Myomas, Leiomyomas, or Fibromas, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
Uterine fibroids are the most common benign tumors of the female reproductive system and are frequently encountered in women of reproductive age. Although many fibroids are asymptomatic, 5%-10% of women with infertility have coexisting fibroids, and in a small proportion fibroids may be the only identifiable cause of infertility. Fibroids may impair fertility by altering uterine anatomy, affecting uterine blood supply, inducing abnormal uterine contractions or endometrial peristalsis, and impairing endometrial receptivity.
The impact of fibroids on fertility depends strongly on their type, size, number, and relationship to the uterine cavity. Submucosal fibroids clearly reduce clinical pregnancy, implantation, and live birth rates and increase miscarriage risk in patients undergoing assisted reproductive technology. In contrast, the effect of intramural fibroids, especially those that do not distort the uterine cavity, remains controversial. Some studies suggest no significant effect on IVF outcomes, whereas others report reduced clinical pregnancy and live birth rates. Evidence also suggests that fibroids located close to the endometrium or measuring ≥4 cm may be more clinically relevant for assisted reproduction.
Current guidelines differ regarding whether infertile women with fibroids should undergo myomectomy before IVF. Chinese expert consensus recommends myomectomy for women preparing for pregnancy when fibroid diameter is ≥4 cm, whereas other international guidelines emphasize individualized management and note the lack of high-quality evidence. Existing studies are limited by small sample size, retrospective design, and inconsistent inclusion criteria. Therefore, whether myomectomy improves IVF outcomes in women with non-cavity-distorting intramural or subserosal fibroids remains uncertain.
Imaging plays an important role in fibroid assessment. Transvaginal ultrasound is widely used because it is inexpensive and accessible, but it has limitations in accurately localizing fibroids and detecting small lesions. Pelvic MRI provides more accurate evaluation of fibroid location, size, and relationship to the myometrium and endometrium, and is particularly useful for study eligibility assessment.
This multicenter randomized controlled trial is designed to evaluate whether myomectomy improves IVF outcomes in infertile women with FIGO type IV, V, or VI uterine fibroids measuring 4-6 cm. The study will compare IVF outcomes between women who undergo myomectomy before IVF and women who proceed directly to IVF without fibroid removal. The main objective is to determine whether surgical removal of these fibroids improves cumulative live birth after IVF.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 792 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
This arm receives myomectomy before IVF.
Procedure: Myomectomy
This arm receives IVF directly without surgical intervention for uterine myomas.
Laparoscopic myomectomy is preferred. Abdominal myomectomy is also acceptable. In principle, layered closure with absorbable sutures should be used. If the full thickness of the myometrium is involved, closure should include at least two layers. Intraoperative tubal patency testing must be performed during surgery. If an endometrial polyp is present in a participant undergoing myomectomy, hysteroscopic endometrial polypectomy should be performed during the same operation.
cumulative live birth rate within 1 year after IVF treatment.
number of participants with live birth / total number of participants who initiated treatment x 100%.
Time frame: within 1 year after IVF treatment
Clinical pregnancy rate after IVF
Visualization of an intrauterine gestational sac by transvaginal ultrasound after embryo transfer, with or without yolk sac, fetal heartbeat, or fetal pole. Calculation: number of clinical pregnancy cycles/number of embryo transfer cycles x 100%.
Time frame: within 1 year of IVF
Biochemical pregnancy rate after IVF
a pregnancy state in which blood hCG is positive after embryo transfer but subsequently decreases, and no gestational sac is visualized by ultrasound. Calculation: number of biochemical pregnancy cycles / total number of cycles x 100%.
Time frame: within 1 year of IVF
Ongoing pregnancy rate after IVF
Ongoing pregnancy is defined as an IVF pregnancy that progresses to 20 weeks of gestation or beyond. Calculation: number of pregnancy cycles with fetal heartbeat beyond 20 weeks / number of embryo transfer cycles x 100%.
Time frame: within 1 year of IVF
Miscarriage rate after IVF
Miscarriage rate is defined as the proportion of pregnancy losses after clinical pregnancy. Calculation: number of miscarriages after clinical pregnancy / total number of clinical pregnancies x 100%.
Time frame: within 1 year of IVF
Pregnancy-related complications
These include ectopic pregnancy, preterm birth, premature rupture of membranes, fetal distress, uterine rupture, fibroid degeneration during pregnancy, gestational diabetes mellitus, hypertensive disorders of pregnancy, and other relevant complications.
Time frame: within 1 year of IVF
No study locations are listed for this record.
Plan to share: No
Start is estimated for May 2026; primary completion for Jun 2028, 25 months later.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 25 months is close to that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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