Ovarian Stimulation With Recombinant Gonadotropins vs. Human Menopausal Gonadotropin in In Vitro Fertilization
Controlled Ovarian Stimulation With Recombinant Follicle Stimulating Hormone Plus Recombinant Luteinizing Hormone vs. Human Menopausal Gonadotropin in In Vitro Fertilization: Retrospective Analysis of Real Life Data
1 other identifier
observational
848
1 country
1
Brief Summary
The purpose of this retrospective study was to assess the outcome of In Vitro Fertilization (IVF) according to the type of medication used for controlled ovarian stimulation (COS). The study compared the pregnancy rate obtained by 398 patients who had received COS with recombinant Follicle Stimulating Hormone (rFSH) plus recombinant Luteinising Hormone (rLH) in 2:1 ratio vs. the one observed in 450 patients who had been treated with human Menopausal Gonadotropin (hMG), stratifying results according to the number of retrieved oocytes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedDecember 23, 2014
December 1, 2014
4.4 years
December 17, 2014
December 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy rate per embryo transfer (PR/ET)
First transvaginal US examination three weeks after a positive pregnancy test
Study Arms (2)
Group A
Patients who had been stimulated with a starting dose of 150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio.
Group B
Patients who had been stimulated with a starting dose of 150-300 IU/d hMG.
Interventions
150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio
Eligibility Criteria
Infertile women requiring IVF and classified as expected poor responders and/or expected normal responders on the basis of age, basal FSH circulating levels, anti-mullerian Hormone (AMH) circulating level and basal antral follicle count.
You may qualify if:
- infertility
- need to undergo IVF
- circulating basal FSH above 6.5 UI/l
- circulating AMH 0.1-2 ng/ml
- basal antral follicle count between 3 and 15
You may not qualify if:
- circulating basal FSH below 6.5 UI/l
- circulating AMH below 0.1 ng/ml or above 2 ng/ml
- basal antral follicle count below 3 or above 15
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Torino, 10126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Revelli, MD PhD
Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Study Record Dates
First Submitted
December 17, 2014
First Posted
December 23, 2014
Study Start
March 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 23, 2014
Record last verified: 2014-12