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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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01604044
Enrollment
579
Registered
2012-05-23
Start date
2012-05-31
Completion date
2013-09-30
Last updated
2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

Brief summary

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

Interventions

DRUGMeropur 150 a day

one subcutaneous injection a day

DRUGGonal-f 150 plus Luveris 150

one subcutaneous injection a day

Sponsors

Catholic University of the Sacred Heart
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 41 Years
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.

Design outcomes

Primary

MeasureTime frame
ongoing pregnancy rate12 weeks

Secondary

MeasureTime frame
number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies30 days

Other

MeasureTime frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026