Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Fertility Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

late start (day 4) vs. corifollitropin-alfa standard start (day 2)

Interventions

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Corifollitropin Alfa

late start (day 4) vs. corifollitropin-alfa standard start (day 2)

Intervention Type DRUG

Eligibility Criteria

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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