Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.
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ClinicalTrials.gov Identifier: NCT00820482 |
Recruitment Status :
Completed
First Posted : January 12, 2009
Last Update Posted : September 18, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Stimulation Preceding Intrauterine Insemination | Drug: Menopur®, Ferring Drug: rFSH (Gonal®, | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
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. |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Group A
Group A: 75 UI/day of Hp-hMG (Menopur®, Ferring, Copenhaghen, Dinamarca)
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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)
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Drug: rFSH (Gonal®,
75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono) |
- 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 outcomes: - Days of stimulation - Total doses of gonadotrophins administrated - Clinical pregnancy , ongoing pregnancy and miscarriage rate - Cancellation rate [ Time Frame: one cycle ]

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

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
Spain | |
IVI Valencia | |
Valencia, Spain, 46117 | |
IVI Valencia | |
Valencia, Spain, 4 |
Principal Investigator: | Elena Labarta, MD | IVI Valencia |
Responsible Party: | Dr. Elena Labarta, Instituto Valenciano de Infertilidad, Spain |
ClinicalTrials.gov Identifier: | NCT00820482 |
Other Study ID Numbers: |
VLC- EL-0106-307-9 |
First Posted: | January 12, 2009 Key Record Dates |
Last Update Posted: | September 18, 2009 |
Last Verified: | September 2009 |
Menotropins Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |