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

Infertility Clinical Trial

— RIOT-A  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946684
• Other study ID #: RIOTA2015
• Secondary ID: 2015-005682-24H-
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 1, 2017
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Letrozole
Adjuvant therapy to recFSH during ovarian stimulation
• Placebo
Adjuvant therapy to recFSH during ovarian stimulation

Locations

Country	Name	City	State
Denmark	Department of Fertility, Juliane Marie Centeret	Copenhagen	Capitol Region
Denmark	Unit of Reproductive Medicine, Herlev Hospital	Herlev	Capital Region
Denmark	Clinic of Fertility, Holbæk Hospital	Holbæk	Region Of Zealand
Denmark	Clinic of Fertility, Hvidovre Hospital	Hvidovre	Capitol Region

Sponsors (7)

Lead Sponsor	Collaborator
Sven O. Skouby	Copenhagen University Hospital, Denmark, Holbaek Sygehus, Hvidovre University Hospital, Region Capital Denmark, Rigshospitalet, Denmark, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum progesterone level		Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years)
Secondary	Serum estradiol, testosterone and androstenedione levels		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.
Secondary	P and 17-hydroxyprogesterone (17-HP) Area Under the Curve.		Assessed during stimulation treatment throughout the study completion, up to 3 years.
Secondary	Follicular fluid concentration of estradiol, testosterone, inhibin B and AMH levels		Assessed during stimulation treatment (throughout the study completion, up to 3 years
Secondary	Total IU of Follicle Stimulating Hormone used per cycle.		Assessed throughout study completion, up to 3 years
Secondary	Number of follicles > 12 mm		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
Secondary	Number of oocytes obtained oocytes obtained.		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
Secondary	Proportion of oocytes resulting in top quality day 2, day 3 embryos or day 5/6 embryos according to validated morphological criteria.		Assessed at day 2-3 after oocyte pick up following stimulation (throughout study completion, up to 3 years)
Secondary	Oocyte fertilization rate		Assessed during stimulation treatment (throughout the study completion, up to 3 years
Secondary	Number and quality of embryos obtained, including rate of blastocyst formation.		Assessed during stimulation treatment (throughout the study completion, up to 3 years
Secondary	Endometrial thickness in millimeters		Assessed throughout the study completion, up to 3 years
Secondary	Implantation rate		Assessed during stimulation treatment (throughout the study completion, up to 3 years
Secondary	Biochemical pregnancy rate		Assessed 2 weeks after embryo transfer following stimulation (throughout study completion, up to 3 years)
Secondary	Clinical pregnancy rate		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.
Secondary	Morphokinetic parameters of embryo quality as measured using a Time Lapse analysis in centers employing this technology.		Assessed from time of oocyte pick-up to embryo transfer following stimulation (throughout study completion, up to 3 years)
Secondary	Reported side effects		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.