A Phase 2/3 interventional study of Placebo and Letrozole in Infertility, sponsored by Sven O. Skouby. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Sven O. Skouby · Phase 2/3, Interventional, and Treatment
The goal of this project is to identify autocrine, paracrine and endocrine factors which are associated with intercycle variation in cyclical follicle recruitment.
Patients will be monitored in a natural cycle, a stimulated cycle and a follow up. In the stimulated cycle patients will be randomized to co-treatment with aromatase inhibitor or placebo during ovarian stimulation.
The primary aim of this project is to explore the putative cyclic recruitment 'gatekeeping' functions of gonadotropins, sex steroids, anti-muellarian hormone and pregnancy associated plasma protein A in normal ovulatory cycles, and the impact of ovarian stimulation on cyclic follicle recruitment in the following cycle.
It is further proposed that supra-physiological levels of estradiol and progesterone which arise from ovarian stimulation may modulate the size of the secondarily recruited follicle cohort in the next cycle. In order to explore the relative contribution of sex steroids as determinants of the size of the next cycle 'wave' of recruitment further, a second aim of this study will be investigate whether limiting the rise in sex steroid levels during ovarian stimulation, by co-treatment with aromatase inhibitor impacts on cyclic recruitment.
2,540 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's enrollment of 33 is below the median of 120 across 1,722 interventional studies indexed under Infertility.
Browse Infertility studies →Sven O. Skouby is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
2 tablets of placebo are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 International Units of recFSH
Drug: Placebo
2 tablets of 2,5 mg Letrozole are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 International Units of recFSH
Drug: Letrozole
Adjuvant therapy to recFSH during ovarian stimulation
Also known as: Lactose Monohydrate
Adjuvant therapy to recFSH during ovarian stimulation
Also known as: Aromatase Inhibitor
Size of follicle cohort in relation to serum endocrine and paracrine markers
Markers for analysis include: anti-muellerian hormone, estradiol, follicle stimulating hormone, luteinizing hormone, testosterone, androstenedione, progesterone,17-hydroxyprogesterone, pregnancy associated plasma protein A and A2, Inhibin A and B, Bone morphogenic protein
Time frame: The change in size of follicle cohort in relation to change in endocrine and paracrine markers assessed throughout the study completion, up to 3 years.
Size of the cyclically recruited follicle cohort after ovarian stimulation with and without co-treatment with Aromatase Inhibitor.
Time frame: The change in size of follicle cohort throughout the study completion, up to 3 years.
Expression of cytokine and growth factors in endometrial secretions following co-treatment with Aromatase Inhibitor compared with placebo control.
Time frame: Assessed in stimulated cycle at time of embryo transfer (throughout study completion, up to 3 years).
Serum E2, P, Tst and Androstenedione levels
Time frame: The change in levels throughout the study completion, up to 3 years.
Area under the curve for P and 17-hydroxyprogesterone.
Time frame: The change in levels throughout the study completion, up to 3 years.
Total International Units of Follicle Stimulating Hormone used per treatment cycle.
Time frame: Assessed throughout study completion, up to 3 years.
Number of follicles > 12 mm
Time frame: Assessed throughout the study completion, up to 3 years.
Number of oocytes obtained
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Proportion of oocytes resulting in top quality day 2, day 3 embryos or day 5/6 embryos according to validated morphological criteria.
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Oocyte fertilization rate
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Number and quality of embryos obtained.
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Endometrial thickness
Time frame: Assessed throughout the study completion, up to 3 years.
Uterine contraction rate (contractions/minute)
Time frame: Assessed throughout the study completion, up to 3 years.
Implantation rate
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Reported side effects
Time frame: From start of stimulation and administration of study medication to pregnancy scan week gestational age 7-8. Assessed throughout the study completion, up to 3 years.
Morphokinetic parameters of embryo quality as measured using a Time Lapse analysis.
Time frame: Assessed from time of oocyte pick-up to embryo transfer following stimulation (throughout study completion, up to 3 years)
Clinical pregnancy rate
Time frame: Pregnancy scan at gestational age week 7-8 (3-4 weeks after the positive hCG in serum) Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Follicular fluid endocrine and paracrine markers following co-treatment with Aromatase Inhibitor compared with placebo control.
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Biochemical pregnancy rate
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years).
Area under the curve for E2, P and LH
Time frame: The change in levels throughout the study completion, up to 3 years.
Plan to share: Yes — The study will share data with Study RIOT-A
Ran from Aug 2016 to primary completion in Jan 2018, 17 months.
Of 16 phase 2/3 interventional studies under Infertility, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 37. This study's 17 months is below that.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Letrozole
Sven O. Skouby