NCT01337531

Brief Summary

Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 19, 2011

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

April 14, 2011

Last Update Submit

April 18, 2011

Conditions

Polycystic Ovary Syndrome

Keywords

Ovarian Response in PCOSpregnancy rate in PCOSmiscarriage rate in PCOS

Outcome Measures

Primary Outcomes (1)

  • Ovarian Response

    0-15 days post gonadotropin administration

Secondary Outcomes (1)

  • Pregnancy rate

    12-15 days post embryo replacement

Study Arms (2)

gonadotropin

EXPERIMENTAL

recombinant or highly purified gonadotropin

Drug: Gonal-F, Fostimon

Gonadotropins

ACTIVE COMPARATOR

recombinant versus highly purified gonadotropin

Drug: Gonal-F, Fostimon

Interventions

Gonal-F, FostimonDRUG

dosage form

Also known as: Recombinant Gonadotropin, Highly purified Gonadotropin
gonadotropin

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS
  • Primary infertility
  • No other fertility manifestation

You may not qualify if:

  • Non PCOS
  • Secondary infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesis Centre for Fertility and Human Pre-implantation Genetics

Limassol, 3025, Cyprus

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

follitropin alfaGonadotropins

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Savvas N Koundouros, PhD

    Genesis Center for Fertility and Human Pre-implantation Genetics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 19, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

April 19, 2011

Record last verified: 2011-04

Locations

CY(1)