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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Infertility

Treatments: Drug: GnRH analog and recombinant human FSH; Drug: Clomifene Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01389713

clomid re-007

Details and patient eligibility

About

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).

Enrollment: 289 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 2 patient groups

High doses

Active Comparator group

Description:

Administration of high doses of gonadotrophins to stimulate ovarian follicular growth

Treatment:

Drug: GnRH analog and recombinant human FSH

Clomid

Experimental group

Description:

Administration of Clomiphene Citrate to obtain ovarian follicular growth

Treatment:

Drug: Clomifene Citrate