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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 848
- Locations
- 1
- Primary Endpoint
- Pregnancy rate per embryo transfer (PR/ET)
Study Overview
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.
Detailed Description
Data were retrospectively collected from the clinical charts of our In Vitro Fertilization (IVF) Unit database. Among 3,416 cases recorded in the database, patients classified as expected poor responders and/or expected normal responders, requiring an average daily gonadotropin dose of 150-300 IU, were selected. A total of 848 patients matched this criterion and were included in the final analysis; of these, 398 (Group A) had been stimulated with rFSH+rLH, whereas 450 (Group B) had been treated with hMG.
Patients in Group A (n=398) had been stimulated either with a starting dose of 150-300 International Units per day (IU/d) recombinant Follicle Stimulating Hormone (rFSH) plus 75-150 IU/d recombinant Luteinising Hormone (rLH) in 2:1 ratio. On day 6-7 of ovarian stimulation, the gonadotropin dose had been adapted according to the ovarian response, always maintaining the same rFSH:rLH ratio.
Patients in Group B (n=450) had received 150-300 IU/d human Menopausal Gonadotropin, eventually adjusting the dose on day 6-7 of ovarian stimulation.
Either medication had been administered within a "long" protocol with Gonadotropin-releasing Hormone (GnRH)-agonist or a "short" protocol with GnRH-antagonist. The COS regimen (type of protocol and type of medication) had been prescribed in the absence of any pre-fixed criteria at the time of prescription by different physicians of the Unit, basing the choice of appropriate dosages on the clinical experience, considering parameters such as age, small antrall follicle count and basal day 3 FSH.
The classical "long" protocol had been performed administering the GnRH-agonist buserelin (900 mcg/d intranasally) from day 21 of the preceding cycle. In the "short" protocol, the GnRH-antagonist cetrorelix had been started at a subcutaneous dose of 0.25 mg/d according to a flexible schedule, when at least one follicle ≥14 mm diameter was observed at ultrasound (US).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: rFSH plus rLH (Drug)
Group B
Patients who had been stimulated with a starting dose of 150-300 IU/d hMG.
Intervention: hMG (Drug)
Outcomes
Primary Outcomes
Pregnancy rate per embryo transfer (PR/ET)
Time Frame: First transvaginal US examination three weeks after a positive pregnancy test
Secondary Outcomes
No secondary outcomes reported
Investigators
Alberto Revelli
Director Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
University of Turin, Italy