Pregnancy Outcomes Following Myomectomy
Key facts
- Who runs it
- Centro di Ricerca Clinica Salentino
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 150 people enrolled
- Started
- 28 Jun 2024
- Ended
- 30 Dec 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Myomectomy
- Record updated
- 23 January 2026
Who can take part
- Age
- 25 years to 45 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- women of reproductive age (up to 45 yrs)-all groups
- women who had myomectomy (group A and B)/CS (group C) at least two years before the enrolment
- myomas 30 mm in size and larger (groups A and B)
- Study groups: myomectomy performed as hysteroscopic/laparoscopic/laparotomic myomectomy or cesarean myomectomy, both using transendometrial or serosal approach: gravida 2 para 2 or gravida 1 para 1 [groups A1, A2, A3 and groups B1 and B2]
- Control group: women who had cesarean section in their second pregnancy-para 2 gravida 2, at least two years after the CS [group C]
Who cannot take part
- any previous surgery on reproductive organs except myomectomy
- previous treatment for any malignant disease
- previous GTD
- history of endometriosis or PID
- coagulation disorders
- premature ovarian failure or any kind of ovarian insufficiency necessitating oocyte donation
- systemic diseases: IBD, MS, DM
- any additional operation during cesarean myomectomy procedure except cesarean section
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The most prevalent genital pathology, uterine fibroids have a detrimental impact on the health of women. Fibroid symptoms are typically more impactful on females and frequently require uterine excision. Although contentious in terms of how it affects pregnancy outcomes, hysteroscopic, laparoscopic, or laparotomic myomectomy has always been a necessary and suitable procedure for the patient's health. Numerous studies have been conducted on the topic, but no clear findings have been reached.
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The goal of this observational study is to investigate the pregnancy outcomes after hysteroscopic, laparoscopic, laparotomic myomectomies in female patients affected by fibroids. The main questions it aims to answer are:
To investigate pregnancy outcomes in relation to surgical approach used for myomectomy.
To investigate whether pregnancy outcome is different in relation to time when myomectomy was performed: on a pregnant uterus or on a non-gravid uterus.
If there is a comparison group: Researchers will compare a group of patients unsubmitted to surgery, to see the difference with the operated patients.
Participants will follow up, to evaluate the possible pregnancy complications, the intraoperative complications and other perinatal and post-operative complications.
The 2 groups in the trial
- Treated patiens' Group as Group 1
Patients submitted to hysteroscopic, laparoscopic or laparotomic myomectomy
Treatment: Myomectomy
- Untreated patiens' Group as Group 2
Control group - unoperated patients
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pregnancy Outcomes Following Hysteroscopic, Laparoscopic and Laparotomic Myomectomy
- Record updated
- 23 January 2026