Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.

Female Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604044
• Other study ID #: Meropur2009
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2012
• Last updated: September 4, 2014
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 41 Years

Eligibility

Inclusion Criteria:

• women with story of infertility sine causa and mild-moderate male factor

• regular ovulatory menstrual cycles

• BMI =27 kg/m2

• normal day 3 hormonal pattern

• bilateral tubal patency

Exclusion Criteria:

• mono/bilateral tubal occlusion,

• severe male factor

• polycystic ovarian syndrome or any systemic disease or endocrine or metabolic abnormalities

• pelvic inflammatory disease

• endometriosis

• sexual organ malformations

• neoplasms or breast pathology incompatible with gonadotropin stimulation.

Study Design

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

Related Conditions & MeSH terms

• Female Infertility
• Infertility, Female

Intervention

Drug:
• Meropur 150 a day
one subcutaneous injection a day
• Gonal-f 150 plus Luveris 150
one subcutaneous injection a day

Locations

Country	Name	City	State
Italy	Policlinico Agostino Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of stimulation, total gonadotropin dose, number of midsize follicles, dominant follicles, E2 levels, endometrial thickness on hCG day, Progesterone levels, endometrial thickness on the midluteal phase.		30 days	Yes
Primary	ongoing pregnancy rate		12 weeks	Yes
Secondary	number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies		30 days	Yes