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NCT01980680 Clinical Trial

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

Infertility Clinical Trial

— GnRHa trigger  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01980680
Other study ID # Agonist5
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date May 2020

Study information
Verified date December 2020
Source Regionshospitalet Viborg, Skive
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 2020
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• hCG

• Progesterone and Estradiol

Locations
Country Name City State
Denmark The Fertility Clinic, Regional Hospital of Skive Skive

Sponsors (1)
Lead Sponsor Collaborator
Peter Humaidan

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ongoing pregnancy rate per patient 10th week of gestation.
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