Completed

NCT Number: NCT00820482

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Stimulation Preceding Intrauterine Insemination

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IVI Valencia, Valencia, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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…)

Treatment and study plan

Menopur®, Ferring

Drug

75 UI/day of Hp-hMG (Menopur®)

rFSH (Gonal®,

Drug

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

Primary 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 proporción 1:1. Mean outcome: - Ovarian response according to the protocol used.

Time frame: one month

Secondary outcomes

Secondary outcomes: - Days of stimulation - Total doses of gonadotrophins administrated - Clinical pregnancy , ongoing pregnancy and miscarriage rate - Cancellation rate

Time frame: one cycle

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study 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.

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jan 12, 2009
Registry last updated: Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.