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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: hCG; Drug: Progesterone and Estradiol

• Registration Number: NCT01980680
• Lead Sponsor: Peter Humaidan

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Study Start: 2014-12
• Primary Completion: 2019-09
• Study Completion: 2020-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Agonist trigger	hCG	Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG)
hCG	Progesterone and Estradiol	hCG trigger Pregnyl (hCG) and Progesterone and Estradiol

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate per patient	10th week of gestation.

Trial Locations

Locations (1)

The Fertility Clinic, Regional Hospital of Skive; 🇩🇰 Skive, Denmark