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Impact of three endothelial preparation protocols on clinical outcomes of first transfer of frozen-thawed embryos in patients with PCOS: a prospective randomized controlled study

Impact of three endothelial preparation protocols on clinical outcomes of first transfer of frozen-thawed embryos in patients with PCOS: a prospective randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079982
Enrollment
Unknown
Registered
2024-01-17
Start date
2024-01-22
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

PCOS

Interventions

HRT:Endothelial preparation using a hormone replacement program
GnRH-a HRT:Endothelial preparation using a GnRH-a hormone replacement program
LE:Endothelial preparation with letrozole

Sponsors

Department of Obstetrics and Gynecology, Second Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 38 Years

Inclusion criteria

Inclusion criteria: (1) <38 years of age; (2) Diagnosis of PCOS after exclusion of other endocrine disorders and fulfillment of 2 of the Rotterdam criteria: polycystic changes of the ovaries (PCOM); clinical manifestations of hyperandrogenism and/or hyperandrogenemia; and menstrual abnormalities such as sporadic ovulation or anovulation; (3) Patients with indications for IVF/ICSI-FET procedure; (4) Hysteroscopy within 12 months did not show significant abnormalities; (5) Patients and their families voluntarily participated in this study, understood the related rights and risks, and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Presence of unilateral or bilateral hydrosalpinx without surgical removal or ligation of the fallopian tubes; (2) Women with previously diagnosed uterine abnormalities such as uterine malformations (unicornuate uterus, uterine septum, bicornuate uterus, or bicornuate uterus), adenomyosis, submucous fibroids, or uterine adhesions, endometriosis, untreated endometrial polyps, and endometritis; (3) Previous endometrial thickness <7 mm; (4) Women with abnormal chromosomal karyotypes but not chromosomal polymorphisms or their partners; (5) Repeated spontaneous abortions (including biochemical pregnancies) and repeated implantation failures (defined as 3 or more spontaneous abortions and embryo implantation failures); (6) Women with contraindications to assisted reproductive technology and/or pregnancy disorders such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver enzyme test results); renal disease or abnormal serum renal function; severe anemia; history of deep vein thrombosis, pulmonary embolism, or cerebral vascular accident; uncontrolled hypertension or known symptomatic heart disease; (or suspected) history of cervical, endometrial or breast cancer history; undiagnosed vaginal bleeding; (7) Use of combination medications or any other condition that, in the opinion of the investigator, interferes with the conduct of the trial or does not ensure the safety and validity of the data, as well as patients who are unable to comply with study procedures.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate;

Secondary

MeasureTime frame
pregnancy outcome;neonatal outcome;Safety indicators;

Countries

China

Contacts

Public ContactJu Ying

Department of Obstetrics and Gynecology, Second Affiliated Hospital of Air Force Military Medical University

5803439@qq.com+86 29 8477 7690

Outcome results

None listed

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