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.
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ClinicalTrials.gov Identifier: NCT01604044 |
Recruitment Status
:
Completed
First Posted
: May 23, 2012
Last Update Posted
: September 5, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Female Infertility | Drug: Meropur 150 a day Drug: Gonal-f 150 plus Luveris 150 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 579 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |
Arm | Intervention/treatment |
---|---|
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
|
- ongoing pregnancy rate [ Time Frame: 12 weeks ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 35 Years to 41 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

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
Italy | |
Policlinico Agostino Gemelli | |
Rome, Italy, 00168 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Rosanna Apa, professor, Catholic University of the Sacred Heart |
ClinicalTrials.gov Identifier: | NCT01604044 History of Changes |
Other Study ID Numbers: |
Meropur2009 |
First Posted: | May 23, 2012 Key Record Dates |
Last Update Posted: | September 5, 2014 |
Last Verified: | September 2014 |
Additional relevant MeSH terms:
Infertility Infertility, Female Genital Diseases, Male Genital Diseases, Female |