Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH women.

This open-label monocentric, randomized comparative trial, to receive the two different standard clinical practice treatments:

• 1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH)

• 2 vials of Menopur: (vials/powder hMG 75IU).

Follicular development were monitored until the protocol hCG requirement is met and a single injection of hCG was administered.

Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm), pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25 nanomole/Liter (nmol/L).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro Riproduzione e Andrologia
• Treatments: Hormones; Menotropins

Criteria

Inclusion Criteria:

• WHO Type I HH Women

• Serum LH <1.2 IU/L

• Serum FSH <5 IU/L

• Age 25-36 years

• No ovarian tumor

• No cyst

• ≤ 13 small follicles (mean diameter ≤ 10mm)

• BMI between 18 - 32 Kg/m2

• no systemic diseases

Exclusion Criteria:

-