Pretreatment With Estradiol Valerate

NCT01218386 | Completed Phase 4

• 1 other identifier: 2010-019924-30
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is set up to evaluate the efficacy of a programmation by administration of estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days during the luteo-follicular transition period of the menstrual cycle.

Conditions

Infertility

Keywords

ICSI; GnRH antagonists; planning

Outcome Measures

Primary Outcomes (1)

• number of egg retrievals on weekend days

  up to 9 months

Secondary Outcomes (1)

• The mean number of coc in each treatment group

  up to 9 months

Study Arms (2)

Study Group

EXPERIMENTAL

Start with estradiol valerate (Progynova, 2x2mg per day, 2mg in the morning, 2mg in the evening), orally, during 6-10 consecutive days from day 25 of the cycle onwards. If day 25 is Monday: 6 days Tuesday: 10 days Wednesday: 9 days Thursday: 8 days Friday: 7 days Saturday: 6 days Sunday: 6 days of Progynova, 2x2 mg per day After this pretreatment: Standard GnRH antagonist treatment protocol with start rFSH (Puregon®) at a dose of 150 IU From day 2 of the cycle onwards; GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation

Drug: Estradiol valerate

Control group

ACTIVE COMPARATOR

Standard GnRH antagonist treatment protocol with start rFSH (Puregon®) at a dose of 150 IU From day 2 of the cycle onwards; GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation

Drug: Estradiol valerate

Interventions

Estradiol valerate DRUG

Experimental group: estradiol valerate (Progynova, 2x2mg per day, 2mg in the morning, 2mg in the evening), orally, during 6-10 consecutive days from day 25 of the cycle onwards. Both groups:start rFSH (Puregon®) at a dose of 150 IU GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation.

Also known as: Progynova

Control group; Study Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< 36 years old on day of randomisation FSH \< 12 (in the early follicular phase) Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
• Regular menstrual cycles of 21-35 days, presumed to be ovulatory. BMI between 18 and 29 (both inclusive) 1st or 2nd trial IVF or ICSI

You may not qualify if:

• ≥ 36 years old on day of randomisation Endometriosis ≥ grade 3 PCOS Poor responders (development of \< 4 follicles in a previous IVF/ICSI cycle) Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel, Centre for Reproductive Medicine

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Paul Devroey, MD, PhD

  Universitair Ziekenhuis Brussel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 28, 2012

Record last verified: 2012-03

Locations

BE (1)