NCT02994550

Brief Summary

The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation

Trial Health

100
On Track

Trial Health Score

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

Enrollment
447

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2017

Shorter than P25 for early_phase_1

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

First Submitted

Initial submission to the registry

December 1, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

December 1, 2016

Last Update Submit

August 2, 2022

Conditions

Sub-Fertility

Keywords

FSHLHIVF

Outcome Measures

Primary Outcomes (1)

  • Pregnancy achievement

    To report our results in terms of pregnancy per embryo transfer

    3 months after drug administration

Study Arms (2)

FSH/LH 2/1

EXPERIMENTAL

dose: 300IU FSHrec and 150IU LHrec

Drug: FSH/LH

FSH/LH 4/1

EXPERIMENTAL

dose: 300IU FSHrec and 75IU LHrec

Drug: FSH/LH

Interventions

FSH/LHDRUG
FSH/LH 2/1FSH/LH 4/1

Eligibility Criteria

Age35 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF cycles in Cruces University Hospital.
  • Signed IVF and cryopreservation informed consent.
  • Age \>35 and \<40 years.
  • FSH levels \<10 mIU/ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

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

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 16, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

August 4, 2022

Record last verified: 2022-08