NCT01980680

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

4.8 years

First QC Date

October 28, 2013

Last Update Submit

December 16, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate per patient

    10th week of gestation.

Study Arms (2)

Agonist trigger

EXPERIMENTAL

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

Drug: hCG

hCG

ACTIVE COMPARATOR

hCG trigger Pregnyl (hCG) and Progesterone and Estradiol

Drug: Progesterone and Estradiol

Interventions

hCGDRUG
Agonist trigger
Progesterone and EstradiolDRUG
hCG

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic, Regional Hospital of Skive

Skive, 7800, Denmark

Location

MeSH Terms

Conditions

Infertility

Interventions

ProgesteroneEstradiol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesEstrenesEstranesEstradiol Congeners

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 11, 2013

Study Start

December 1, 2014

Primary Completion

September 1, 2019

Study Completion

May 1, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations

DK(1)