Clinical trial NCT03816670: Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF
Official title: Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Disorders
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also performed in specific subgroups of patients: expected poor-responders, expected normal responders and expected hyper-responders

Detailed description: The investigators hypothesize that:

1. CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa late start might show differences in terms of efficacy such as in poor-responder patients.
2. CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates with a similar safety profile with respect to COS performed using CF-alfa standard administration (day 2) in expected normal, poor, or high responders.
3. Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard.
4. The patients' satisfaction will possibly be higher using CF-alfa late start than with CF-alfa standard expecially in those patients who will not have the need to add further daily recFSH injections

Eligibility criteria: Inclusion Criteria:

* aged 18- 43 years
* Male or tubal infertility with indication for IVF treatment
* No PCOS
* No previous IVF treatments in the past two months
* No history of previous Ovarian Hyperstimulation Syndrome (OHSS)
* No previous IVF cycle with more than 30 growing follicles ≥ 11 mm
* Antral Follicle Count (AFC) \<20
* No ovarian cyst nor malignant ovarian tumour, breast, uterus or central nervous cancer

Exclusion Criteria:

* AMH \< 0.2 ng/ml
* Età \> 43 anni

Primary outcomes:
measure: number of retrieved oocytes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Study officials:
References:
citation: Revelli A, Gennarelli G, Sestero M, Canosa S, Carosso A, Salvagno F, Pittatore G, Filippini C, Benedetto C. A prospective randomized trial comparing corifollitropin-alpha late-start (day 4) versus standard administration (day 2) in expected poor, normal, and high responders undergoing controlled ovarian stimulation for IVF. J Assist Reprod Genet. 2020 May;37(5):1163-1170. doi: 10.1007/s10815-020-01742-5. Epub 2020 Mar 18.