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InfertilityPhase 2/3RIOT-ANCT02946684

Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment

A Phase 2/3 study testing Letrozole in people with Infertility, run by Sven O. Skouby at 4 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters during IVF. 128 patients will be randomized to either placebo or active treatment. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
4 sitesDenmark
Study dates
1 Feb 2017to 30 Oct 2018
Phase
Phase 2/3
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 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Indication for IVF/ICSI treatment
  • Eligible for IVF/ICSI treatment according to local criteria
  • Regular cycles 21-35 days (both included)
  • Age < 40
  • AMH 8- 32 (both included)
  • Written consent

Who cannot join

  • Any contraindication for IVF/ICSI treatment according to local criteria
  • Previous stimulation for IVF/ICSI with < 4 oocytes obtained
  • PCOS
  • Undergoing IVF/ICSI for the purpose of fertility preservation
  • Allergy towards study drug

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • Department of Fertility, Juliane Marie Centeret

    Copenhagen, Capitol Region, 2100

  • Unit of Reproductive Medicine, Herlev Hospital

    Herlev, Capital Region, 2730

  • Clinic of Fertility, Holbæk Hospital

    Holbæk, Region of Zealand, 4300

  • Clinic of Fertility, Hvidovre Hospital

    Hvidovre, Capitol Region, 2650

Other trials in Denmark

About this study

Official title: Reducing the Impact of Ovarian Stimulation - The RIOT Project. Study RIOT-A: The Role of Aromatase Inhibitor in Reducing the Detrimental Effects of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles

This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters during IVF. 128 patients will be randomized to either placebo or active treatment.

Read the detailed description

The aim of the study is to investigate whether the detrimental effects of ovarian stimulation on outcomes in fresh embryo transfer cycles be ameliorated by co-treatment with aromatase inhibitors? The research questions are:

  1. Can the impact of ovarian stimulation on late follicular phase sex steroid levels (and hence endometrial receptivity) be mitigated by co-treatment with aromatase inhibitors during ovarian stimulation?
  2. Does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the midluteal phase
Conditions
Infertility
Being tested
Letrozole, Placebo
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LetrozoleDrug

    Also called Aromatase Inhibitor

    Adjuvant therapy to recFSH during ovarian stimulation

  • PlaceboDrug

    Also called Lactose Monohydrate

    Adjuvant therapy to recFSH during ovarian stimulation

Study groups in NCT02946684
Study groupRoleWhat they receive
Lactose MonohydratePlacebo comparator2 tablets of placebo are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH
Receives: Drug: Placebo
Letrozole 5mgActive comparator2 tablets of 2,5mg Letrozole are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH
Receives: Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum progesterone level

    Measured: Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years)

Secondary outcomes (15)

  1. Serum estradiol, testosterone and androstenedione levels

    Measured: Assessed on stimulation day 5, day of hCG administration (or the day before), day 7 and 10 after hCG administration. Assessed throughout study completion, up to 3 years.

  2. P and 17-hydroxyprogesterone (17-HP) Area Under the Curve.

    Measured: Assessed during stimulation treatment throughout the study completion, up to 3 years.

  3. Follicular fluid concentration of estradiol, testosterone, inhibin B and AMH levels

    Measured: Assessed during stimulation treatment (throughout the study completion, up to 3 years

  4. Total IU of Follicle Stimulating Hormone used per cycle.

    Measured: Assessed throughout study completion, up to 3 years

  5. Number of follicles > 12 mm

    Measured: Assessed in stimulated cycle on day of hCG administration or the day before (throughout the study completion), up to 3 years. Cycle length is between 21 and 35 days

  6. Number of oocytes obtained oocytes obtained.

    Measured: Assessed in stimulated cycle at time of oocyte pick up after follicle aspiration (throughout the study completion, up to 3 years).Cycle length is between 21 and 35 days

  7. Proportion of oocytes resulting in top quality day 2, day 3 embryos or day 5/6 embryos according to validated morphological criteria.

    Measured: Assessed at day 2-3 after oocyte pick up following stimulation (throughout study completion, up to 3 years)

  8. Oocyte fertilization rate

    Measured: Assessed during stimulation treatment (throughout the study completion, up to 3 years

  9. Number and quality of embryos obtained, including rate of blastocyst formation.

    Measured: Assessed during stimulation treatment (throughout the study completion, up to 3 years

  10. Endometrial thickness in millimeters

    Measured: Assessed throughout the study completion, up to 3 years

  11. Implantation rate

    Measured: Assessed during stimulation treatment (throughout the study completion, up to 3 years

  12. Biochemical pregnancy rate

    Measured: Assessed 2 weeks after embryo transfer following stimulation (throughout study completion, up to 3 years)

  13. Clinical pregnancy rate

    Measured: Pregnancy scan at gestational age week 7-8 (3-4 weeks after the positive hCG in serum). Assessed throughout study completion, up to 3 years.

  14. Morphokinetic parameters of embryo quality as measured using a Time Lapse analysis in centers employing this technology.

    Measured: Assessed from time of oocyte pick-up to embryo transfer following stimulation (throughout study completion, up to 3 years)

  15. Reported side effects

    Measured: From start of stimulation and administration of study medication to pregnancy scan week gestational age 7-8. Assessed throughout study completion, up to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study start1 Feb 2017
  3. Primary completion30 Oct 2018
  4. Study completion30 Oct 2018

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02946684
Sponsor's protocol ID
RIOTA2015
Other IDs
2015-005682-24, H-15021850, HGH-2016-045_04513, 2015
Acronym
RIOT-A
Status last verified
Jul 2019
First submitted
11 Jul 2016
Last updated
8 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bulow NS, Warzecha AK, Nielsen MV, Andersen CY, Holt MD, Petersen MR, Sopa N, Zedeler A, Englund AL, Pinborg A, Grondahl ML, Skouby SO, Macklon NS. Impact of letrozole co-treatment during ovarian stimulation on oocyte yield, embryo development, and live birth rate in women with normal ovarian reserve: secondary outcomes from the RIOT trial. Hum Reprod. 2023 Nov 2;38(11):2154-2165. doi: 10.1093/humrep/dead182.

    PubMed 37699851

  • Bulow NS, Skouby SO, Warzecha AK, Udengaard H, Andersen CY, Holt MD, Grondahl ML, Nyboe Andersen A, Sopa N, Mikkelsen ALE, Pinborg A, Macklon NS. Impact of letrozole co-treatment during ovarian stimulation with gonadotrophins for IVF: a multicentre, randomized, double-blinded placebo-controlled trial. Hum Reprod. 2022 Jan 28;37(2):309-321. doi: 10.1093/humrep/deab249.

    PubMed 34792133

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Letrozole in people with Infertility, run by Sven O. Skouby at 4 sites in Denmark.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum progesterone level (time frame: Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years)). 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 NCT02946684, which also lists 2 linked publications.

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 8 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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