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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2020-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Agonist trigger

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

Group Type EXPERIMENTAL

hCG

Intervention Type DRUG

hCG

hCG trigger Pregnyl (hCG) and Progesterone and Estradiol

Group Type ACTIVE_COMPARATOR

Progesterone and Estradiol

Intervention Type DRUG

Interventions

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hCG

Intervention Type DRUG

Progesterone and Estradiol

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No