MedDataX Logo

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

NCT ID: NCT01980680

Last Updated: 2020-12-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hCG

Intervention Type DRUG

Progesterone and Estradiol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peter Humaidan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Humaidan

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Fertility Clinic, Regional Hospital of Skive

Skive, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Agonist5

Identifier Type: -

Identifier Source: org_study_id