Step Up Versus Step Down in Controlled Ovarian Stimulation

Parc de Salut Mar

Status and phase: Completed; Phase 4

Conditions: No Explained Sterility

Treatments: Drug: FSH-r (Follicule stimulate hormone)

Study type: Interventional

Funder types: Other

Identifiers

NCT01376999

UREP-01-2009

Details and patient eligibility

About

The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination.

Enrollment: 158 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with unexplained sterility with needs of intrauterine insemination.

Exclusion criteria

• Contraindications to intrauterine insemination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

158 participants in 2 patient groups

Step Down

Experimental group

Description:

Step Down: We begin the COS (controlled ovarian stimulation) with 150 IU of FSH-r until 7th day of stimulation. This day we make an adjustment reducing the dose if necessary.

Treatment:

Drug: FSH-r (Follicule stimulate hormone)

Step Up

Active Comparator group

Description:

Step up: We begin the COS (controlled ovarian stimulation) with 75 IU of FSH-r until 7th day of stimulation.This day we make an adjustment increasing the dose if necessary.

Treatment:

Drug: FSH-r (Follicule stimulate hormone)