PCOSNCT05227391
Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS
A study testing Oral Letrozole and Oral estradiol valerate in people with PCOS, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Oral Letrozole and Oral estradiol valerate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,078 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. women diagnosed with PCOS according to modified Rotterdam criteria;
- 2. Women who are participating in their first cycle of IVF or ICSI.
- 3. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol.
- 4. Women with whole embryos freezing.
- 5. Women aged 20 to 38 years old;
- 6. Women BMI 18 kg/m2 to 30 kg/m2
- 7. 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.
Who cannot join
- 1. Women who has a history of recurrent spontaneous abortion.
- 2. Women with unilateral/bilateral oophorectomy.
- 3. Women with untreated Hydrosalpinx.
- 4. 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.
- 5. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension.
- 6. Women who are indicated and planned to undergo preimplantation genetic test (PGT).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive & Genetic Hospital of CITIC-Xiangya
Changsha, Hunan, 410000
Yuan Li, doctor, +86-731-84566688, 1002251255@qq.com
Fei Gong, PhD
About this study
Official title: Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial
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.
- Conditions
- PCOS
- Being tested
- Oral Letrozole, Oral estradiol valerate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral LetrozoleProcedure or surgery
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 valerateProcedure or surgery
Oral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| Letrozole-stimulated group | Experimental | Not described Receives: Procedure: Oral Letrozole |
| Hormone replacement treatment group | Active comparator | Not described Receives: Procedure: Oral estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 months
Secondary outcomes (8)
Clinical pregnancy rate
Number of women with clinical pregnancy /number of women randomized to the specific group. Clinical pregnancy was defined as the presence of at least one gestational sac in the uterine cavity on ultrasound at about 28 days after embryo transfer.
Measured: 2 months
Biochemical pregnancy rate
Number of women with biochemical pregnancy /number of women randomized to the specific group. Biochemical pregnancy was defined as a human chorionic gonadotropin level of more than 10 milli-International unit (mIU) per milliliter (ml) as measured at about 14 days after embryo transfer.
Measured: 1.5 months
Miscarriage rate
Number of women with miscarrage / number of women with clinical pregnancy. Miscarriage refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
Measured: 9 months
Cycle cancellation rate
Number of women who initiated endometrial preparation without embryos transfer / number of women randomized to the specific group.
Measured: 1 month
Birth weight
Weight of newborns at delivery.
Measured: 11 months
Incidence of obstetric and perinatal complications
Number of pregnancies with complications / number of clinical pregnancies.
Measured: 11 months
Incidence of neonatal complications
Number of live births with neonatal complications / number of live births.
Measured: 11 months
Ectopic pregnancy rate
Number of women with ectopic pregnancy /number of women randomized to the specific group. Ectopic pregnancy will be defined as implantation outside the uterine cavity, as confirmed by sonography or laparoscopy.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start16 Mar 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 1,078 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227391
- Sponsor's protocol ID
- P2022001
- Status last verified
- Jun 2023
- First submitted
- 26 Jan 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37591656
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05227391
- Acronym / sponsor ID
- P2022001
- Conditions
- PCOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,078 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole-stimulated group | Experimental | Procedure: Oral Letrozole |
| Hormone replacement treatment group | Active comparator | Procedure: Oral estradiol valerate |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. women diagnosed with PCOS according to modified Rotterdam criteria;
- 2. Women who are participating in their first cycle of IVF or ICSI.
- 3. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol.
- 4. Women with whole embryos freezing.
- 5. Women aged 20 to 38 years old;
Key exclusion criteria (6 listed)
- 1. Women who has a history of recurrent spontaneous abortion.
- 2. Women with unilateral/bilateral oophorectomy.
- 3. Women with untreated Hydrosalpinx.
- 4. 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.
- 5. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral LetrozoleOral 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. | Procedure or surgery | Letrozole-stimulated group |
| Oral estradiol valerateOral estradiol valerate at a dose of 3mg twice daily will be started on days 3-5 of the menstrual cycle. | Procedure or surgery | Hormone replacement treatment group |
Primary outcome
Live birth rate
Time frame: 11 months
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.
8 secondary outcomes
Clinical pregnancy rate
Time frame: 2 months
Biochemical pregnancy rate
Time frame: 1.5 months
Miscarriage rate
Time frame: 9 months
Cycle cancellation rate
Time frame: 1 month
Birth weight
Time frame: 11 months
Incidence of obstetric and perinatal complications
Time frame: 11 months
Incidence of neonatal complications
Time frame: 11 months
Ectopic pregnancy rate
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 37591656Wang 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Letrozole and Oral estradiol valerate in people with PCOS, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 11 months). 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 NCT05227391, which also lists 1 linked publication.
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 22 Jun 2023.