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

September 17, 2009 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

A Prospective, Randomized, Controlled Trial Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination: Ovarian Response and Clinical Outcomes.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46117
        • IVI Valencia
      • Valencia, Spain, 4
        • IVI Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

  • Principal Investigator: Elena Labarta, MD, IVI Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VLC- EL-0106-307-9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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