NCT02013973

Brief Summary

The primary aim of this trial is to compare two groups of women undergoing IVF (IVF=in vitro fertilisation ) treatment, to investigate if assessment of AMH (AMH=Anti-Müllerian hormone ), in addition to assessment of maternal age, AFC (AFC=antral follicle count ) and BMI (BMI=body mass index ) gives a more optimal COH (COH=controlled ovarian stimulation than does assessment of only age, AFC and BMI, measured as number of patients obtaining 5-12 oocytes during COH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

3.2 years

First QC Date

December 6, 2013

Last Update Submit

December 11, 2016

Conditions

Infertility

Keywords

Anti mullerian hormoneIn vitro fertilizationOptimal treatmentRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Number of patients obtaining 5-12 oocytes during COH

    2 years

Secondary Outcomes (5)

  • Cancelled cycle rate

    2 years

  • Total dose of gonadotropins

    2 years

  • Number of participants developing moderate or severe OHSS

    2 years

  • Embryology

    2 years

  • Pregnancy and live birth rate

    2 years

Study Arms (2)

AMH-group

EXPERIMENTAL

The patients randomized to the AMH-group calculation of gonadotropin starting dose will be made from an algorithm including age, BMI, AFC and AMH-analysis.

Other: AMH-analysis

Non-AMH-group

NO INTERVENTION

The patients randomized to the non-AMH-group, calculation of gonadotropin starting dose will be made from an algorithm including only age, BMI and AFC

Interventions

AMH-analysisOTHER

At the first visit to the IVF-clinic a blood sample for serum-AMH is taken and frozen for later analysis in the AMH-group. The AMH assay used is the Beckman Coulter AMH Gene II assay. The analysis result will be added to the algorthm deciding what starting gonadotropin dose the patient is having.

AMH-group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Indication for IVF with standard method for the couple exists (i.e. more than one year of infertility and work-up has been performed suggesting IVF as the proper treatment and no known severe male factor exists).
  • Age \>18 and \< 40 years.
  • BMI \> 18 and \< 35.
  • First IVF treatment for the woman.
  • Willing to participate in randomization between intervention group and control group and to sign informed consent.

You may not qualify if:

  • IVF with ICSI (ICSI=intracytoplasmic sperm injection ) planned.
  • Oocyte donation planned.
  • Treatment with PGD (PGD=preimplantation genetic diagnosis ) planned.
  • Medical or psychological condition indicating ineligibility for the study.
  • Patient with insufficient knowledge of Swedish language to understand patient information.
  • Previous participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital, Reproductive medicine,

Gothenburg, SE-41345, Sweden

Location

Related Publications (1)

  • Magnusson A, Olerod G, Thurin-Kjellberg A, Bergh C. The correlation between AMH assays differs depending on actual AMH levels. Hum Reprod Open. 2017 Dec 8;2017(4):hox026. doi: 10.1093/hropen/hox026. eCollection 2017.

    PMID: 30895238DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Christina Bergh, MD PhD

    Sahlgrenska University Hospital

    STUDY CHAIR

  • Ann Thurin-Kjellberg, MD PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 17, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

SE(1)