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Optimal Interval to Pregnancy After Myomectomy: A Multicenter Randomized Controlled Trial

Optimal Interval to Pregnancy After Myomectomy: A Multicenter Randomized Controlled Trial and AI-Assisted Decision-Model Development

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112650
Enrollment
Unknown
Registered
2025-11-18
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine fibroids

Interventions

Shortened interpregnancy interval group:Short-term contraception for 6 months following myomectomy
Conventional Interpregnancy Interval Group:12-month contraception after myomectomy

Sponsors

International Peace Maternity & Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in the study: (1) Age 20-45 years; (2) 6-8 weeks after undergoing myomectomy (laparoscopic/laparotomy/hysteroscopic) with confirmed absence of postoperative complications such as infection or hemorrhage; (3) FIGO type I-VI leiomyomas, and the myomectomy procedure did not involve full-thickness penetration of the uterine wall; (4) Have a clear desire for future pregnancy and wish to conceive within 2 years after surgery; (5) Normal uterine cavity morphology post-surgery; (6) Signed informed consent.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: (1) FIGO type 0 or VII leiomyomas, full-thickness uterine penetration during myomectomy, or diffuse uterine leiomyomatosis; (2) Coexisting untreated intrauterine adhesions, endometriosis stage III-IV (ASRM classification), tubal obstruction, or ovarian insufficiency; (3) Presence of severe medical comorbidities, active autoimmune disease, or history of malignancy; (4) History of thromboembolic disease, hormone-dependent tumors, or uncontrolled hepatic dysfunction constituting a clear contraindication to surgery; (5) Established pregnancy; (6) Planned participation in other clinical trials involving reproductive interventions, or use of long-acting hormonal medications within the past 3 months; (7) Inability to comply with follow-up or refusal to use the prescribed contraceptive regimen.

Design outcomes

Primary

MeasureTime frame
Incidence of myomectomy-associated adverse pregnancy outcomes;

Secondary

MeasureTime frame
Cumulative live birth rate;Natural conception rate;Miscarriage rate;Cesarean section rate;Clinical pregnancy rate;

Countries

China

Contacts

Public ContactXu Hong

International Peace Maternity and Child Health Hospital

xuhong1168@126.com+86 180 1731 6266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026