The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients (GnRHa trigger)

December 16, 2020 updated by: Peter Humaidan

The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Randomized Controlled Pilot Study in Normo-responder IVF Patients

After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the corpora lutea (CL).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Skive, Denmark, 7800
        • The Fertility Clinic, Regional Hospital of Skive

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 20 and 40
  • Normal menstrual cycles: 25-34 days
  • Oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)
  • BMI >18 and <35 kg/m2

Exclusion Criteria:

  • Patients with >14 follicles on day of trigger
  • Previous hyperresponse with OHSS development
  • Previous low response (less than 3 oocytes on a high dose of FSH stimulation)
  • Endocrine disorders

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Agonist trigger
Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG)
Drug: hCG
Active Comparator: hCG
hCG trigger Pregnyl (hCG) and Progesterone and Estradiol
Drug: Progesterone and Estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rate per patient
Time Frame: 10th week of gestation.
10th week of gestation.

Collaborators and Investigators

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

Sponsor

Peter Humaidan

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

December 1, 2014

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

October 28, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Agonist5

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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