Back to resultsHighly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
Primary Purpose
Female Infertility
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Meropur 150 a day
Gonal-f 150 plus Luveris 150
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility
Eligibility 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.
Sites / Locations
- Policlinico Agostino Gemelli
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
HP-hMG
rFSH plus rLH
Arm Description
Outcomes
Primary Outcome Measures
ongoing pregnancy rate
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
Full Information
NCT ID
NCT01604044
First Posted
May 21, 2012
Last Updated
September 4, 2014
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT01604044
Brief Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
5. Study Description
Brief Summary
This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
579 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HP-hMG
Arm Type
Active Comparator
Arm Title
rFSH plus rLH
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Meropur 150 a day
Intervention Description
one subcutaneous injection a day
Intervention Type
Drug
Intervention Name(s)
Gonal-f 150 plus Luveris 150
Intervention Description
one subcutaneous injection a day
Primary Outcome Measure Information:
Title
ongoing pregnancy rate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Policlinico Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25398971
Citation
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.
Results Reference
derived
Learn more about this trial
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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