Infertility Therapy for Women Age Thirty-eight and Older — FORT-T  

Infertility Clinical Trial

Official title: Optimal Infertility Therapy RCT: Women 40 and Older

Status Active, not recruiting

Clinical Trial Summary

This study will determine the most effective treatment strategy for infertile couples who present when the female partner is 38 years to the 43rd birthday and the couples are determined to have a reasonable chance for success.

Clinical Trial Description

We hypothesize that infertile couples with the female partner 38-43 years of age and demonstrating an adequate ovarian reserve will have higher pregnancy rates at no more cost through immediate IVF than they would through infertility treatment in which IVF is preceded by either two cycles of clomiphene with IUI or two cycles of FSH with IUI.

This hypothesis is being tested by conducting a randomized clinical trial of couples in which the female partner between her 38th and 43rd birthday and determined to have normal ovarian reserve by CCT, and who would otherwise be candidates for ovulation induction/IUI as their initial treatment. The trial will evaluate the efficacy, cost and cost-effectiveness of three alternative infertility treatment strategies: (1) two cycles of clomiphene/IUI followed by IVF, (2) two cycles of FSH/IUI followed by IVF, and (3) immediate IVF; the IVF treatment will include a maximum of four fresh cycles of IVF and two thaw cycles. The trial has the following specific aims:

Aim 1: To compare the proportion of women with a clinically recognized intrauterine pregnancy after two cycles of treatment with clomiphene/IUI, FSH/IUI, or IVF.

Aim 2: To evaluate the overall effectiveness of the three treatment strategies, and their associated complications.

Aim 3: To evaluate the costs and cost effectiveness of the three treatment strategies, including direct and indirect medical costs.

The study participants will be involved in the study for varying amounts of time. The duration of the study will be determined by the treatment cycle in which the participant becomes pregnant. It could be as short as several months' treatment plus the duration of the pregnancy or it could be as long as several years if the participant does not get pregnant or takes breaks during treatment.

This is a collaborative study between Dartmouth College, Boston IVF, Brigham and Women's Hospital, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, and Tufts Health Plan.

Total expected enrollment: 450 Couples ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

• NCT number: NCT00246506
• Study type: Interventional
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2003
• Completion date: April 2013