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NCT Number: NCT06604091

Cohort Profile：The Shandong Adenomyosis Cohort of Population Undergoing Reproductive Technology (SAart)

Previous studies have shown that compared with infertile women without adenomyosis, the clinical pregnancy rate, live birth rate and continuous pregnancy rate of women with adenomyosis significantly reduce, and the abortion rate obviously increased. However, these studies lack a definite classification of adenomyosis, so the true effect of adenomyosis with different severity on pregnancy outcomes are not clear. Our research team intends to collect clinical data of infertility patients with adenomyosis receiving IVF and the detailed classification of adenomyosis according to MUSA criteria. Finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female In Vitro Fertilization Urogenital Diseases Uterine Diseases

Age range

20 year–37 year

Sex eligibility

Female

Study type

Observational

Primary location

The Second Clinical Hospital of Shandong University

Jinan, Shandong, 250033, China

About this study

Previous studies have shown that compared with infertile women without adenomyosis, the clinical pregnancy rate, live birth rate and continuous pregnancy rate of women with adenomyosis significantly reduce, and the abortion rate obviously increased. However, these studies lack a definite classification of adenomyosis, so the true effect of adenomyosis with different severity on pregnancy outcomes are not clear. Our research team intends to collect clinical data of infertility patients with adenomyosis receiving IVF and the detailed classification of adenomyosis according to MUSA and ultrasound consensus. Finally, we can have an objective recognition of adenomyosis on pregnancy outcomes, which also bring benefits to evidence-based clinical practice.

The detailed inclusion and exclusion criteria are as follows:

Inclusion criteria

1.Age of all participants ≥ 20 and < 38 years. 2.Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors.

3.Conforming to MUSA criteria. 4. Body mass index < 30 kg/m2. 5.The level of AMH ≥ 0.8 ng/ml. Exclusion criteria

  • Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids > 3 cm).
  • Untreated endometrial polyps, hydrosalpinx or uterine adhesions.
  • RSA or RIF.
  • Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
  • Concurrent and/or recent involvement in other research within previous 3 months of study enrolment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of all participants ≥ 20 and< 38 years.
  • Receiving IVF treatment because of adenomyosis or other common factor, such as fallopian tube factors.
  • Conforming to MUSA criteria.
  • Body mass index < 30 kg/m2.
  • The level of AMH ≥ 0.8 ng/ml.

Exclusion criteria

  • Uterine fibroids (International Federation of Gynecology and Obstetrics (FIGO) type 0--I--II or type III--IV fibroids < 3 cm).
  • Untreated endometrial polyps, hydrosalpinges or uterine adhesions.
  • RSA or RIF.
  • Intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT).
  • Concurrent and/or recent involvement in other research within previous 3 months of study

Treatment and study plan

Treatment protocol

Other

Treatment options for ovarian stimulation include long-acting and antagonist regimens and other ovulation induction regimens. Options for frozen embryo transfer include natural protocols, mild ovarian stimulation regimens, hormone replacement therapy (HRT) regimens, and down-regulated combined HRT regimens. The treatment regimen is refined in the above protocol. The treatment of patients follows the principles of real-world clinical practice.

Primary outcomes

  1. cumulative live birth rate

    Time frame: from pregnancy to delivery

    The numerator is number of live births from fresh or frozen embryo transfer in one ovarian stimulation cycle. More than one live birth is considered as one live birth. Denominator is defined as patients who have undergone oocyte retrieval and have either achieved at least one live birth or who have no surplus embryos.

Secondary outcomes

  1. implantation rate

    Time frame: from transplantation to delivery

    IR is the ratio of the total number of gestational sacs confirmed by TVUS to the total number of transferred embryos.

  2. biochemical pregnancy rate

    Time frame: from transplantation to pregnancy

    Serum β-hCG level ≥ 10 mIU/mL is defined as biochemical pregnancy.

  3. ectopic pregnancy rate

    Time frame: from transplantation to clinical pregnancy

    Ectopic pregnancy is defined as the presence of extra-uterine gestational sacs or masses.

  4. miscarriage rate

    Time frame: pregnancy loss before 28 gestational weeks

    Miscarriages mean pregnancy loss before 28 gestational weeks. Clinical pregnancy loss ≤ 12 gestational weeks is an early miscarriage, and pregnancy loss between 12 and 28 gestational weeks is a late miscarriage.

  5. clinical pregnancy rate

    Time frame: pregnancy loss before 28 gestational weeks

    Clinical pregnancy is defined as visible intra-uterine pregnancy or extra-uterine pregnancy.

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Sep 19, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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