Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico289 enrolled

Overview

Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

289

Conditions

Infertility

Interventions

Clomifene Citrate

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 18-42 years * infertility status * Day 3 serum FSH \> 12 IU/ml in at least two occasions or previous poor response (≤3 oocytes retrieved) to hyper-stimulation Exclusion Criteria: * contraindications to infertility treatments or pregnancy

Outcomes

Primary Outcomes

live birth rate

general "Live birth rate" will be recorded at the end of the study when all participants have performed their In vitro Fertilization (IVF) treatment. Live birth rate per single patients will be recorded 4 weeks after embryo transfer when a intrauterine gestational sac is expected to be seen in case of pregnancy.

Time frame: end of the study (28 months)

Secondary Outcomes

ratio pregnancies/costs

at the end of the study the number of obtained pregnancies will be divided by the total costs of treatments in two groups. A cost in euros will be therefore estimated for every single pregnancy in both groups.