Influence of FSH/LH Ratio in Controlled Ovarian Stimulation

August 2, 2022 updated by: Antonia Exposito, Hospital de Cruces

Influence of FSH/LH Ratio in Controlled Ovarian Stimulation ( 2/1 Ratio vs 4/1 Ratio) in >35 Years Women Undergoing IVF

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • When inclusion criteria are not fulfilled

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FSH/LH 2/1
dose: 300IU FSHrec and 150IU LHrec
Drug: FSH/LH
EXPERIMENTAL: FSH/LH 4/1
dose: 300IU FSHrec and 75IU LHrec
Drug: FSH/LH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy achievement
Time Frame: 3 months after drug administration
To report our results in terms of pregnancy per embryo transfer
3 months after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Cruces

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 13, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIC E14/30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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