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:

ClinicalTrials.gov Identifier:

NCT01604044

First Posted: May 23, 2012

Last Update Posted: September 5, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Rosanna Apa, Catholic University of the Sacred Heart

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment

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

Primary Outcome Measures:

ongoing pregnancy rate [ Time Frame: 12 weeks ]

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 ]

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 ]


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

Information from the National Library of Medicine

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Ages Eligible for Study:	35 Years to 41 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604044

Locations


Italy
Policlinico Agostino Gemelli
Rome, Italy, 00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moro F, Scarinci E, Palla C, Romani F, Familiari A, Tropea A, Leoncini E, Lanzone A, Apa R. Highly purified hMG versus recombinant FSH plus recombinant LH in intrauterine insemination cycles in women ≥35 years: a RCT. Hum Reprod. 2015 Jan;30(1):179-85. doi: 10.1093/humrep/deu302. Epub 2014 Nov 14.


Responsible Party:	Rosanna Apa, professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:	NCT01604044 History of Changes
Other Study ID Numbers:	Meropur2009
First Submitted:	May 21, 2012
First Posted:	May 23, 2012
Last Update Posted:	September 5, 2014
Last Verified:	September 2014

Additional relevant MeSH terms:


Infertility Infertility, Female Genital Diseases, Male Genital Diseases, Female

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