NCT02625519

Brief Summary

Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.

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
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2015

Typical duration for phase_4

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

November 9, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

November 9, 2015

Last Update Submit

August 27, 2018

Conditions

Reproductive Techniques, Assisted

Keywords

Controlled ovarian stimulationFollicle-stimulating hormoneReceptor N680S follicle-stimulating hormone receptor (FSHR)Gene polymorphismOocyte donors

Outcome Measures

Primary Outcomes (1)

  • number of cumulus-oocyte complexes obtained

    number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation

    through study completion, an average of 2 weeks

Secondary Outcomes (7)

  • number of metaphase II (MII) oocytes

    through study completion, an average of 2 weeks

  • number of useful oocytes (inseminated or microinjected)

    through study completion, an average of 2 weeks

  • duration of stimulation (days)

    through study completion, an average of 2 weeks

  • FSH treatment units obtained by oocyte

    through study completion, an average of 2 weeks

  • FSH treatment cost per oocyte obtained

    through study completion, an average of 2 weeks

  • +2 more secondary outcomes

Study Arms (2)

Urinary follicle-stimulating hormone

EXPERIMENTAL

Controled Ovarian stimulation with urinary follicle-stimulating hormone

Drug: Urinary follicle-stimulating hormone

Recombinant follicle-stimulating hormone

EXPERIMENTAL

Ovarian stimulation with recombinant follicle-stimulating hormone

Drug: Recombinant follicle-stimulating hormone

Interventions

Urinary follicle-stimulating hormoneDRUG

Ovarian stimulation with highly purified urinary follicle-stimulating hormone

Also known as: urinary FSH, Fostipur®
Urinary follicle-stimulating hormone
Recombinant follicle-stimulating hormoneDRUG

Controled ovarian stimulation with recombinant follicle-stimulating hormone

Also known as: recombinant FSH, Bemfola®
Recombinant follicle-stimulating hormone

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be considered eligible to get into the oocyte donation program of Instituto Bernabeu
  • Age between 18 and 30 years
  • Body Mass Index over 18 and under 28
  • Antral follicle count greater than 9 and less than 25 (adding both ovaries)
  • Patients starting ovarian stimulation with 225 IU of FSH
  • Presence of both ovaries
  • Ability to participate and comply with the study protocol
  • Signing the written consent form
  • Not having received treatment with ovulation stimulators in the 3 months prior to stimulation

You may not qualify if:

  • Concurrent participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Bernabeu

Alicante, 03016, Spain

RECRUITING

MeSH Terms

Conditions

Helping Behavior

Interventions

UrofollitropinGlycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

MenotropinsGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsChorionic GonadotropinFollicle Stimulating HormoneLuteinizing HormoneThyrotropinPlacental Hormones

Study Officials

  • Joaquín Llácer

    Instituto Bernabeu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquín Llácer

CONTACT

965 154 000jllacer@institutobernabeu.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynaecologist. Reproductive Medicine Specialist at Institute Bernabeu

Study Record Dates

First Submitted

November 9, 2015

First Posted

December 9, 2015

Study Start

December 1, 2015

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

ES(1)