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Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00820482
First Posted: January 12, 2009
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
  Purpose
The present study aims to elucidate if the FSH and LH activity contained in hMG preparations is comparable to the recombinant FSH and LH administration in a 1:1 ratio. The mean outcome is the corresponding ovarian response in terms of oestradiol increase during stimulation and number of mature follicles the day of hCG administration. The patients will be included and randomized into two groups and stimulated either by HMG injections started on day 3 at a dose of 75 IU every day and fixed for the first 5 days, and in the second group, rFSH and rLH injections be started on day 3 at a dose of 75 UI/day of rFSH + 75UI/day of rLH. Serum estradiol levels will be measured on stimulation day 1, day 6 and the day of hCG injection. All follicles greater than 14 mm of diameter will be recorded on hCG day Intrauterine insemination is performed during two consecutive days starting the day after the human chorionic gonadotrophin (Ovitrelle) injection. Secondary outcomes are Days of stimulation, Total doses of gonadotrophins administrated, Clinical pregnancy , Ongoing pregnancy and Miscarriage rate, and Cancellation rate.

Condition Intervention Phase
Ovarian Stimulation Preceding Intrauterine Insemination Drug: Menopur®, Ferring Drug: rFSH (Gonal®, Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Trial Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination: Ovarian Response and Clinical Outcomes.

Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • The present study aims to elucidate if the FSH and LH activity contained in hMG preparations is comparable to the recombinant FSH and LH administration in proporción 1:1. Mean outcome: - Ovarian response according to the protocol used. [ Time Frame: one month ]

Secondary Outcome Measures:
  • Secondary outcomes: - Days of stimulation - Total doses of gonadotrophins administrated - Clinical pregnancy , ongoing pregnancy and miscarriage rate - Cancellation rate [ Time Frame: one cycle ]

Estimated Enrollment: 80
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
Group A: 75 UI/day of Hp-hMG (Menopur®, Ferring, Copenhaghen, Dinamarca)
Drug: Menopur®, Ferring
75 UI/day of Hp-hMG (Menopur®)
Experimental: Group B
75UI/day of rFSH (Gonal®, Serono, Ginebra, Suiza) + 75UI/day of rLH (Luveris®, Serono, Ginebra, Suiza)
Drug: rFSH (Gonal®,
75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono)

  Eligibility

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Esterility > 1 year duration
  • < 39 years old
  • REM > 3 millions/ml
  • 1 or 2º IUI cycle

Exclusion criteria:

  • Ovarian policystic syndrome
  • Severe Endometriosis
  • Uterine disease (polyps, myomas, intracavitarios, malformations…)
  Contacts and Locations
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): NCT00820482


Locations
Spain
IVI Valencia
Valencia, Spain, 46117
IVI Valencia
Valencia, Spain, 4
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Principal Investigator: Elena Labarta, MD IVI Valencia
  More Information

Responsible Party: Dr. Elena Labarta, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT00820482     History of Changes
Other Study ID Numbers: VLC- EL-0106-307-9
First Submitted: January 8, 2009
First Posted: January 12, 2009
Last Update Posted: September 18, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs