AzTrials
AzTrials

InfertilityMIONCT07578623

The Impact of Myomectomy on IVF Outcomes: A Multicenter Randomized Controlled Trial

A study testing Myomectomy in people with Infertility and In Vitro Fertilization (IVF), run by Peking Union Medical College Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 40 years, women only
What is being tested?
Myomectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
792 participants
Where
No sites listed yet
Study dates
1 May 2026to 1 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female patients aged 20 years or older and younger than 40 years.
  • Primary infertility or secondary infertility. Infertility factors may include male partner factors, ovulatory disorders, tubal factors, endometriosis, other non-uterine corpus disease factors, or unexplained infertility.
  • Pelvic MRI indicating intramural fibroids: FIGO type 4-6; the largest fibroid has a maximum diameter of at least 4 cm and less than 6 cm; a total of no more than two fibroids measuring 4-6 cm; fibroids smaller than 4 cm may be disregarded.
  • Meets indications for IVF and is willing to undergo IVF treatment.

Who cannot join

  • Infertility factors related to diseases of the uterine corpus, including but not limited to adenomyosis, intrauterine adhesions, endometritis, submucosal fibroids, and multiple endometrial polyps. A single endometrial polyp 1 cm or smaller does not require exclusion.
  • Coexisting malignant or borderline tumors of the reproductive system, or other malignant tumors that are untreated or still under treatment.
  • Active pelvic inflammatory disease.
  • Previous cytotoxic therapy or pelvic/abdominal radiotherapy or chemotherapy.
  • Previous surgery of the uterine corpus, including but not limited to myomectomy, uterine wedge resection, uterine artery embolization, tumor coagulation of the uterine corpus such as high-intensity focused ultrasound or electrocoagulation, and hysteroscopic myomectomy. Prior hysteroscopy, diagnostic curettage, or hysteroscopic polypectomy does not require exclusion.
  • Expected inability to complete follow-up.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lan Zhu, Dr. contact

zhu_julie@vip.sina.com

About this study

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.

Read more

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.

Being tested
Myomectomy
Medical subject headings
Infertility, Leiomyoma, Fibroma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyomectomyProcedure or surgery

    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.

Study groups in NCT07578623
Study groupRoleWhat they receive
Intervention armExperimentalThis arm receives myomectomy before IVF.
Receives: Procedure: Myomectomy
Control armNo interventionThis arm receives IVF directly without surgical intervention for uterine myomas.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: within 1 year after IVF treatment

Secondary outcomes (5)
  1. 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%.

    Measured: within 1 year of IVF

  2. 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%.

    Measured: within 1 year of IVF

  3. 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%.

    Measured: within 1 year of IVF

  4. 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%.

    Measured: within 1 year of IVF

  5. 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.

    Measured: within 1 year of IVF

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a nationwide multicenter randomized controlled trial with a 1:1 allocation ratio between the intervention arm and the control arm. Each participating center will enroll participants competitively. Participants in the intervention arm will be instructed to undergo IVF after myomectomy, whereas participants in the control arm will proceed directly to IVF. A computer-generated randomization sequence will be used. Block randomization with randomly varying block sizes will be applied, with block sizes ranging from 4 to 8. Randomization will be stratified by study center. Allocation concealment will be implemented through a web-based randomization system.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
792 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07578623
Sponsor's protocol ID
K4218
Acronym
MIO
Status last verified
May 2026
First submitted
5 May 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Levens ED, Stegmann BJ, Feinberg EC, Larsen FW. Ultrasonographic characteristics of the endometrium among patients with fibroids undergoing ART. Fertil Steril. 2008 Apr;89(4):1005-7. doi: 10.1016/j.fertnstert.2007.03.096. Epub 2007 Jul 26.

    PubMed 17662279
  • Yoshino O, Hayashi T, Osuga Y, Orisaka M, Asada H, Okuda S, Hori M, Furuya M, Onuki H, Sadoshima Y, Hiroi H, Fujiwara T, Kotsuji F, Yoshimura Y, Nishii O, Taketani Y. Decreased pregnancy rate is linked to abnormal uterine peristalsis caused by intramural fibroids. Hum Reprod. 2010 Oct;25(10):2475-9. doi: 10.1093/humrep/deq222. Epub 2010 Aug 18.

    PubMed 20719814
  • Ng EH, Yeung WS, Ho PC. Endometrial and subendometrial vascularity are significantly lower in patients with endometrial volume 2.5 ml or less. Reprod Biomed Online. 2009 Feb;18(2):262-8. doi: 10.1016/s1472-6483(10)60264-7.

    PubMed 19192348
  • Wang Y, Zhu Y, Sun Y, Di W, Qiu M, Kuang Y, Shen H. Ideal embryo transfer position and endometrial thickness in IVF embryo transfer treatment. Int J Gynaecol Obstet. 2018 Dec;143(3):282-288. doi: 10.1002/ijgo.12681. Epub 2018 Oct 8.

    PubMed 30238667
  • Gallos ID, Khairy M, Chu J, Rajkhowa M, Tobias A, Campbell A, Dowell K, Fishel S, Coomarasamy A. Optimal endometrial thickness to maximize live births and minimize pregnancy losses: Analysis of 25,767 fresh embryo transfers. Reprod Biomed Online. 2018 Nov;37(5):542-548. doi: 10.1016/j.rbmo.2018.08.025. Epub 2018 Oct 6.

    PubMed 30366837
  • Capmas P, Voulgaropoulos A, Legendre G, Pourcelot AG, Fernandez H. Hysteroscopic resection of type 3 myoma: a new challenge? Eur J Obstet Gynecol Reprod Biol. 2016 Oct;205:165-9. doi: 10.1016/j.ejogrb.2016.06.026. Epub 2016 Aug 31.

    PubMed 27607740
  • Casini ML, Rossi F, Agostini R, Unfer V. Effects of the position of fibroids on fertility. Gynecol Endocrinol. 2006 Feb;22(2):106-9. doi: 10.1080/09513590600604673.

    PubMed 16603437
  • Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Removal of myomas in asymptomatic patients to improve fertility and/or reduce miscarriage rate: a guideline. Fertil Steril. 2017 Sep;108(3):416-425. doi: 10.1016/j.fertnstert.2017.06.034.

    PubMed 28865538
  • Perez-Lopez FR, Ornat L, Ceausu I, Depypere H, Erel CT, Lambrinoudaki I, Schenck-Gustafsson K, Simoncini T, Tremollieres F, Rees M; EMAS. EMAS position statement: management of uterine fibroids. Maturitas. 2014 Sep;79(1):106-16. doi: 10.1016/j.maturitas.2014.06.002. Epub 2014 Jun 9.

    PubMed 24975954
  • Marret H, Fritel X, Ouldamer L, Bendifallah S, Brun JL, De Jesus I, Derrien J, Giraudet G, Kahn V, Koskas M, Legendre G, Lucot JP, Niro J, Panel P, Pelage JP, Fernandez H; CNGOF (French College of Gynecology and Obstetrics). Therapeutic management of uterine fibroid tumors: updated French guidelines. Eur J Obstet Gynecol Reprod Biol. 2012 Dec;165(2):156-64. doi: 10.1016/j.ejogrb.2012.07.030. Epub 2012 Aug 29.

    PubMed 22939241
  • Dolmans MM, Isaacson K, Zhang W, Gordts S, Munro MG, Stewart EA, Bourdon M, Santulli P, Donnez J. Intramural myomas more than 3-4 centimeters should be surgically removed before in vitro fertilization. Fertil Steril. 2021 Oct;116(4):945-958. doi: 10.1016/j.fertnstert.2021.08.016. No abstract available.

    PubMed 34579828
  • Yan L, Ding L, Li C, Wang Y, Tang R, Chen ZJ. Effect of fibroids not distorting the endometrial cavity on the outcome of in vitro fertilization treatment: a retrospective cohort study. Fertil Steril. 2014 Mar;101(3):716-21. doi: 10.1016/j.fertnstert.2013.11.023. Epub 2014 Jan 11.

    PubMed 24424367
  • Christopoulos G, Vlismas A, Salim R, Islam R, Trew G, Lavery S. Fibroids that do not distort the uterine cavity and IVF success rates: an observational study using extensive matching criteria. BJOG. 2017 Mar;124(4):615-621. doi: 10.1111/1471-0528.14362. Epub 2016 Dec 5.

    PubMed 27921379
  • Khalaf Y, Ross C, El-Toukhy T, Hart R, Seed P, Braude P. The effect of small intramural uterine fibroids on the cumulative outcome of assisted conception. Hum Reprod. 2006 Oct;21(10):2640-4. doi: 10.1093/humrep/del218. Epub 2006 Jun 21.

    PubMed 16790615
  • Sunkara SK, Khairy M, El-Toukhy T, Khalaf Y, Coomarasamy A. The effect of intramural fibroids without uterine cavity involvement on the outcome of IVF treatment: a systematic review and meta-analysis. Hum Reprod. 2010 Feb;25(2):418-29. doi: 10.1093/humrep/dep396. Epub 2009 Nov 12.

    PubMed 19910322

Questions about this trial

What is this clinical trial studying?

A study testing Myomectomy in people with Infertility and In Vitro Fertilization (IVF), run by Peking Union Medical College Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hanbi Wang, Dr. ((+86)(010)69158620, zhw2005@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cumulative live birth rate within 1 year after IVF treatment. (time frame: within 1 year after IVF treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07578623, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in