Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS
1 other identifier
interventional
1,078
1 country
1
Brief Summary
This is a multicenter randomized controlled trial comparing the efficacy and safety of two endometrial preparation protocols for the first frozen embryo transfer cycle in PCOS with whole embryo freezing. Subjects will be randomized to letrozole-stimulated group or hormone replacement treatment group in their first frozen embryo transfer cycle, and their pregnancy and perinatal outcomes during this cycle will be followed up and analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 22, 2023
June 1, 2023
2.3 years
January 26, 2022
June 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Live birth rate
Number of women with live birth/ number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation.
11 months
Secondary Outcomes (8)
Clinical pregnancy rate
2 months
Biochemical pregnancy rate
1.5 months
Miscarriage rate
9 months
Cycle cancellation rate
1 month
Birth weight
11 months
- +3 more secondary outcomes
Study Arms (2)
Letrozole-stimulated group
EXPERIMENTALHormone replacement treatment group
ACTIVE COMPARATORInterventions
Oral Letrozole at a dose of 2.5mg daily will be started on days 3-5 of the menstrual cycle and will be continued for 5 days.
Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle.
Eligibility Criteria
You may qualify if:
- \. women diagnosed with PCOS according to modified Rotterdam criteria;
- \. Women who are participating in their first cycle of IVF or ICSI.
- \. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol.
- \. Women with whole embryos freezing.
- \. Women aged 20 to 38 years old;
- \. Women BMI 18 kg/m2 to 30 kg/m2
- \. Women with at least one good-quality embryo suitable for transfer, including day 3 cleavage stage embryo with grade 7CI /8CI and day 5 or day 6 blastocyst with grade 4BB or higher.
You may not qualify if:
- \. Women who has a history of recurrent spontaneous abortion.
- \. Women with unilateral/bilateral oophorectomy.
- \. Women with untreated Hydrosalpinx.
- \. Women with a uterine cavity abnormality, such as a uterine congenital malformation, untreated uterine septum (except shallow uterine septum), adenomyosis, submucous myoma, or moderate to severe intrauterine adhesions.
- \. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension.
- \. Women who are indicated and planned to undergo preimplantation genetic test (PGT).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive & Genetic Hospital of CITIC-Xiangya
Changsha, Hunan, 410000, China
Related Publications (1)
Wang X, Li Y, Zhang C, Feng YR, Deng B, Zhang S, Ma Y, Wu Y, Lin G, Gong F. Live birth after letrozole-stimulated cycles versus hormone replacement treatment cycles for the first frozen embryo transfer in women with polycystic ovary syndrome: protocol for a multicentre randomised controlled trial. BMJ Open. 2023 Aug 17;13(8):e072021. doi: 10.1136/bmjopen-2023-072021.
PMID: 37591656DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2022
First Posted
February 7, 2022
Study Start
March 16, 2022
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
June 22, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available from 3 months following first publication and ending 5 years after the study has been concluded.
- Access Criteria
- Individual participant data will be shared with researches who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee.
All the individual participant data collected during the trial will be shared after deidentification upon request. Study protocol, Statistical analysis plan, informed consent forms, and clinical study report will be available upon request. Data will be available from 3 months following first publication and ending 5 years after the study has been concluded. Individual participant data will be shared with researches who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee.