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

Patients With Reduced Ovarian Reserve and In Vitro Fertilization (IVF) Cycles. A Randomized Multicentric Comparison of a Protocol With High Doses of Gonadotropins and a Protocol With Clomiphene Citrate Only. Evaluation of Clinical Effectiveness and Economic Issues

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01389713

Acronym

clomid

Enrollment

289

Registered

2011-07-08

Start date

2008-09-30

Completion date

2010-12-31

Last updated

2011-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

ovarian reserve, ovarian stimulation, clomifene citrate, high doses Follicle Stimulating Hormone (FSH)

Brief summary

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).

Interventions

DRUGClomifene Citrate

3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle

DRUGGnRH analog and recombinant human FSH

daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

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

Design outcomes

Primary

Measure	Time frame	Description
live birth rate	end of the study (28 months)	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.

Secondary

Measure	Time frame	Description
ratio pregnancies/costs	end of the study (28 months)	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026