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

NCT ID: NCT00820482

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-05-31

Brief Summary

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.

Conditions

Ovarian Stimulation Preceding Intrauterine Insemination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Group A: 75 UI/day of Hp-hMG (Menopur®, Ferring, Copenhaghen, Dinamarca)

Group Type: ACTIVE_COMPARATOR

Menopur®, Ferring

Intervention Type: DRUG

75 UI/day of Hp-hMG (Menopur®)

Group B

75UI/day of rFSH (Gonal®, Serono, Ginebra, Suiza) + 75UI/day of rLH (Luveris®, Serono, Ginebra, Suiza)

Group Type: EXPERIMENTAL

rFSH (Gonal®,

Intervention Type: DRUG

75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono)

Interventions

Menopur®, Ferring

75 UI/day of Hp-hMG (Menopur®)

Intervention Type: DRUG

rFSH (Gonal®,

75UI/day of rFSH (Gonal®, Serono) + 75UI/day of rLH (Luveris®, Serono)

Intervention Type: DRUG

Eligibility 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…)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Responsible Party

Instituto Valenciano de Infertilidad, Spain

Principal Investigators

Elena Labarta, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

IVI Valencia

Valencia, Valencia, Spain

IVI Valencia

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

VLC- EL-0106-307-9

Identifier Type: -

Identifier Source: org_study_id