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

Peter Humaidan

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: hCG; Drug: Progesterone and Estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT01980680

Agonist5

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Agonist trigger

Experimental group

Description:

Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG)

Treatment:

Drug: hCG

hCG

Active Comparator group

Description:

hCG trigger Pregnyl (hCG) and Progesterone and Estradiol

Treatment:

Drug: Progesterone and Estradiol