Adenomyosis Patients With Infertility and Immunological Factors
ConditionAdenomyosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorPeking University Third Hospital
About this trial
Infertile patients with adenomyosis who met the inclusion and exclusion criteria, after signing the informed consent form, the researchers recorded the clinical information of the patients and initiated the in vitro fertilization-embryo transfer (IVF-ET) procedure. Peripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation. By analyzing the changes of immune cells and molecules in the peripheral blood of the patients, role of immune factors in infertility combined with adenomyosis was further explored.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients were diagnosed as adenomyosis by transvaginal ultrasound scans (The criteria for sonographic diagnosis of adenomyosis are with 2 or more of the following: heterogeneous myometrial texture with the presence of globular asymmetric uterus, thickening of the anterior and posterior myometrial wall, irregular cystic areas within the myometrium);
18≤ age ≤ 40 years old at first outpatient visit in our Reproductive Center;
with regular menstrual cycle.
Disqualifiers
Patients with intrauterine adhesion, uterine malformation, submucosal leiomyoma, or ≥ 5.0 cm in diameter leiomyoma;
hydrosalpinx and systemic diseases;
patients with other endocrine severe diseases, immune diseases, tumors and abnormal chromosomes in either partner.
Trial population
Infertile patients with adenomyosis who underwent IVF-ET at the Reproductive Center of the Peking University Third Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Venous blood collection
Other interventionPeripheral blood was collected on the day of embryo transfer. And if the pregnancy test was positive at 14 days after embryo transfer, peripheral blood was collected at 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Adenomyosis Cohort1 intervention
Trial outcomes
Primary outcomes
1
Clinical pregnancy rate
Clinical pregnancy denoted evidence of at least one intrauterine gestational sac observed by ultrasonography 30 days after embryo transfer. Clinical pregnancy rate = Number of patients who achieved clinical pregnancy / Number of transplant cycles.
Time frame
Within 10 weeks after embryo transfer2
Miscarriage rate
Miscarriage was defined as the presence of an intrauterine gestational sac but no subsequent live birth after 24 weeks of gestation. Miscarriage rate = Number of patients with miscarriage / Number of patients who achieved clinical pregnancy.
Time frame
Within 24 weeks after embryo transfer3
Live birth rate
Live birth was defined as delivery of a live baby after 24 weeks of gestation. Live birth rate = Number of patients with live birth / Number of transplant cycles.
Time frame
Within 1 year after embryo transferSecondary outcomes
1
Immune cells and molecules in the peripheral blood
Immune cells and molecules in the peripheral blood on the day of embryo transfer, 21 days after the transfer and every 2 weeks thereafter until 12 weeks of gestation.
Time frame
Within 12 weeks of gestationSponsors and contacts
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Source ClinicalTrials.gov