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

Phase 4

Completed

• Conditions: Ovarian Stimulation Preceding Intrauterine Insemination
• Interventions: Drug: Menopur®, Ferring; Drug: rFSH (Gonal®,

• Registration Number: NCT00820482
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-12
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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...)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Menopur®, Ferring	Group A: 75 UI/day of Hp-hMG (Menopur®, Ferring, Copenhaghen, Dinamarca)
Group B	rFSH (Gonal®,	75UI/day of rFSH (Gonal®, Serono, Ginebra, Suiza) + 75UI/day of rLH (Luveris®, Serono, Ginebra, Suiza)

Primary Outcome Measures

Name	Time	Method
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.	one month

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes: - Days of stimulation - Total doses of gonadotrophins administrated - Clinical pregnancy , ongoing pregnancy and miscarriage rate - Cancellation rate	one cycle

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain