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.

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rosanna Apa, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT01604044

First received: May 21, 2012

Last updated: September 4, 2014

Last verified: September 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Female Infertility	Drug: Meropur 150 a day Drug: Gonal-f 150 plus Luveris 150	Phase 1


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

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:

ongoing pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Other Outcome Measures:

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. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]


Enrollment:	579
Study Start Date:	May 2012
Study Completion Date:	September 2013
Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: HP-hMG	Drug: Meropur 150 a day one subcutaneous injection a day
Active Comparator: rFSH plus rLH	Drug: Gonal-f 150 plus Luveris 150 one subcutaneous injection a day

Eligibility


Ages Eligible for Study:	35 Years to 41 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604044

Locations


Italy
Policlinico Agostino Gemelli
Rome, Italy, 00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

More Information

No publications provided


Responsible Party:	Rosanna Apa, professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT01604044 History of Changes
Other Study ID Numbers:	Meropur2009
Study First Received:	May 21, 2012
Last Updated:	September 4, 2014
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 27, 2015

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