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Completed

NCT Number: NCT02946684

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Unit of Reproductive Medicine, Herlev Hospital, Herlev, Capital Region, Denmark

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About this study

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:

  • 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?
  • Does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the midluteal phase

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

letrozole

Drug

Adjuvant therapy to recFSH during ovarian stimulation

Other names: Aromatase Inhibitor

Placebo

Drug

Adjuvant therapy to recFSH during ovarian stimulation

Other names: Lactose Monohydrate

Primary outcomes

  1. Serum progesterone level

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

Secondary outcomes

  1. Serum estradiol, testosterone and androstenedione levels

    Time frame: 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.

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

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

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

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

    Time frame: Assessed throughout study completion, up to 3 years

  5. Number of follicles > 12 mm

    Time frame: 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.

    Time frame: 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.

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

  8. Oocyte fertilization rate

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

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

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

  10. Endometrial thickness in millimeters

    Time frame: Assessed throughout the study completion, up to 3 years

  11. Implantation rate

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

  12. Biochemical pregnancy rate

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

  13. Clinical pregnancy rate

    Time frame: 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.

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

  15. Reported side effects

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sven O. Skouby

Other

Collaborators

  • Copenhagen University Hospital, Denmark
  • Holbaek Sygehus
  • Hvidovre University Hospital
  • Region Capital Denmark
  • Rigshospitalet, Denmark
  • Zealand University Hospital

Registry information

Official study 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

Acronym: RIOT-A

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2016
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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