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Trial record 26 of 2077 for:    ESTRADIOL

Pretreatment With Estradiol Valerate

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ClinicalTrials.gov Identifier: NCT01218386
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : March 28, 2012
Sponsor:
Information provided by (Responsible Party):
Blockeel Christophe, Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Estradiol valerate Phase 4

Detailed Description:
See Section Interventions

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Programmation of GnRH Antagonist Cycles With Estradiol Valerate: Impact on the Stimulation in IVF/ICSI.
Study Start Date : May 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Arm Intervention/treatment
Experimental: Study Group

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

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.

Other Name: Progynova

Active Comparator: Control group
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

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.

Other Name: Progynova




Primary Outcome Measures :
  1. number of egg retrievals on weekend days [ Time Frame: up to 9 months ]

Secondary Outcome Measures :
  1. The mean number of coc in each treatment group [ Time Frame: up to 9 months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

< 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

Exclusion Criteria:

≥ 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218386


Locations
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Belgium
UZ Brussel, Centre for Reproductive Medicine
Brussel, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Study Director: Paul Devroey, MD, PhD Universitair Ziekenhuis Brussel

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Responsible Party: Blockeel Christophe, Dr, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01218386     History of Changes
Other Study ID Numbers: 2010-019924-30
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Keywords provided by Blockeel Christophe, Universitair Ziekenhuis Brussel:
ICSI
GnRH antagonists
planning
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Infertility
Genital Diseases, Male
Genital Diseases, Female
Ganirelix
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Hormone Antagonists