Letrozole in Stimulated IVF Cycles
A Randomized Trial of Letrozole as an Adjunct to Follicle Stimulating Hormone in Stimulated in Vitro Fertilization Cycles
1 other identifier
interventional
900
1 country
2
Brief Summary
In-vitro fertilization (IVF) is the treatment of choice for couples with prolonged infertility. The treatment usually involves hormonal stimulation of the ovaries by follicle stimulating hormone (FSH), followed by surgical removal of eggs which are then mixed with sperm in the laboratory to create embryos. The success rates of IVF treatment remain unsatisfactory and are no longer increasing. One of the reasons is an adverse effect of high serum estradiol levels following FSH stimulation on the lining of the uterus. Letrozole is a drug used in the prevention of recurrence of breast cancer because of its action to reduce the intra-ovarian aromatization of androgens to estrogens. It is now increasingly used for ovulation induction and is as safe as clomiphene citrate. Use of letrozole during standard ovarian stimulation for IVF producing adequate numbers of oocytes with physiological levels of estradiol may increase the present success rate of standard IVF treatment. The aim of this randomized study is to compare the live birth rate of FSH alone versus combined FSH and letrozole used for ovarian stimulation in IVF treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2018
Longer than P75 for phase_3
2 active sites
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
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedMay 10, 2023
November 1, 2022
4.2 years
September 13, 2016
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate
A baby born alive after 20 weeks gestation
through study completion, an average of 1 year
Secondary Outcomes (19)
Miscarriage rate
up to 20 weeks of gestation
Clinical and ongoing pregnancy rates
up to 20 weeks
Ovarian hyperstimulation rate
about 1 month
Total IU of FSH used per cycle
about 2 weeks
Number of follicles > 12 mm on day of hCG (or the day before)
about 2 weeks
- +14 more secondary outcomes
Study Arms (2)
Letrozole group
EXPERIMENTALLetrozole + standard treatment: Daily 150-300 IU human menopausal gonadotrophin (HMG) / Follicle stimulating hormone (FSH) from cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) and co-treatment with letrozole 2.5 mg daily from stimulation day 5 until the day before hCG administration. GnRH antagonist (cetrotide or orgalutran) 0.25 mg daily from stimulation day 5 until the day of hCG administration.
Control group
NO INTERVENTIONStandard treatment: Daily 150-300 IU HMG/FSH cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) until the day before hCG administration. GnRH antagonist 0.25 mg daily from stimulation day 5 until the day of hCG administration.
Interventions
Daily 150-300 IU human menopausal gonadotrophin (HMG) / Follicle stimulating hormone (FSH) from cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) and co-treatment with letrozole 2.5 mg daily from stimulation day 5 until the day before hCG administration. GnRH antagonist (cetrotide or orgalutran) 0.25 mg daily from stimulation day 5 until the day of hCG administration.
Eligibility Criteria
You may qualify if:
- women under 42 years of age
- medical indication for IVF treatment
- antral follicle count prior to ovarian stimulation \>=3
- informed consent
You may not qualify if:
- women using donor oocytes
- women undergoing preimplantation genetic diagnosis
- women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
- women with hydrosalpinges shown on scanning and not corrected
- previous documented poor response (\<=3 oocytes) to ovarian stimulation using at least FSH 225 IU daily
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Peking University Third Hospitalcollaborator
Study Sites (2)
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
Peking University Third Hospital
Beijing, 100191, China
Related Publications (1)
Guo W, Li HWR, Yang Z, Zeng L, Yang R, Qiao J, Li R, Ng EHY. Live birth after letrozole as an adjunct to follicle-stimulating hormone versus follicle-stimulating hormone alone for ovarian stimulation in in vitro fertilisation cycles-study protocol for a randomised controlled trial. Trials. 2022 Apr 1;23(1):247. doi: 10.1186/s13063-022-06185-0.
PMID: 35365197DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest HY Ng, MD
Department of Obstetrics and Gynaecology, The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 23, 2016
Study Start
March 1, 2018
Primary Completion
April 30, 2022
Study Completion
April 30, 2023
Last Updated
May 10, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share