Back to resultsThe Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients (GnRHa trigger)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
hCG
Progesterone and Estradiol
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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
Sites / Locations
- The Fertility Clinic, Regional Hospital of Skive
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Agonist trigger
hCG
Arm Description
Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG)
hCG trigger Pregnyl (hCG) and Progesterone and Estradiol
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate per patient
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01980680
Brief Title
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients
Acronym
GnRHa trigger
Official Title
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Randomized Controlled Pilot Study in Normo-responder IVF Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Humaidan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Agonist trigger
Arm Type
Experimental
Arm Description
Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG)
Arm Title
hCG
Arm Type
Active Comparator
Arm Description
hCG trigger Pregnyl (hCG) and Progesterone and Estradiol
Intervention Type
Drug
Intervention Name(s)
hCG
Intervention Type
Drug
Intervention Name(s)
Progesterone and Estradiol
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate per patient
Time Frame
10th week of gestation.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Fertility Clinic, Regional Hospital of Skive
City
Skive
ZIP/Postal Code
7800
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients
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