NCT01604044

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

May 21, 2012

Last Update Submit

September 4, 2014

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate

    12 weeks

Secondary Outcomes (1)

  • number of cancelled cycles for low or no response, the number of interrupted cycles for high risk of OHSS and multiple pregnancies

    30 days

Other Outcomes (1)

  • 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

Study Arms (2)

HP-hMG

ACTIVE COMPARATOR
Drug: Meropur 150 a day

rFSH plus rLH

ACTIVE COMPARATOR
Drug: Gonal-f 150 plus Luveris 150

Interventions

Meropur 150 a dayDRUG

one subcutaneous injection a day

HP-hMG
Gonal-f 150 plus Luveris 150DRUG

one subcutaneous injection a day

rFSH plus rLH

Eligibility Criteria

Age35 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Agostino Gemelli

Rome, Rome, 00168, Italy

Location

Related Publications (1)

  • 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.

    PMID: 25398971DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

IT(1)