NCT02418533

Brief Summary

This study is for couples pursuing in vitro fertilization (IVF) with preimplantation genetic screening (PGS) of embryos to achieve pregnancy. The objective of this clinical trial is to study the effect of mono-menotropins for COS versus recombinant follicle stimulating hormone (rFSH) on cleavage-stage and blastocyst embryo quality after IVF. Embryo quality parameters include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse parameters, and chromosomal aneuploidy rates after PGS. This pilot study is expected to significantly contribute to optimization of treatment regimens and stimulation protocols to optimize embryo quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

March 31, 2015

Last Update Submit

August 10, 2020

Conditions

InfertilityFertility

Keywords

infertilityin vitro fertilizationfertilitypreimplantation genetic screeningembryoPGSEevaIVF

Outcome Measures

Primary Outcomes (1)

  • Embryo Quality

    Embryo quality parameters include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse parameters, and chromosomal aneuploidy rates after PGS.

    Embryo quality will be assessed on day 3, 5 and 6 of culture

Study Arms (2)

Mono-menotropin protocol

EXPERIMENTAL

Stimulation Group 1: Mono-Menotropin Protocol Fifty patients will undergo the standard of care COS for IVF using Menopur only. Patients will receive 300 IU of Menopur injected subcutaneously daily for the first five days of stimulation. Thereafter, Menopur may be adjusted (to optimize ovarian response by patient's physician) in 75 IU increments up to a total of 450 IU Menopur daily up to and including day of hCG trigger.

Drug: menotropin

rFSH protocol

EXPERIMENTAL

Stimulation Group 2: Recombinant follicle stimulating hormone (rFSH) Protocol Fifty patients will undergo the standard of care COS for IVF using Gonal-f (EMD Serono, USA) Protocol. Patients will receive Gonal-f (300 IU) administered subcutaneously daily for the first five days of stimulation. Thereafter, Gonal-f may be adjusted (to optimize ovarian response by the patient's physician) in 75 IU increments up to a total of 450 IU daily up to and including day of hCG trigger.

Drug: Recominant Follicle Stimulating Hormone (rFSH)

Interventions

menotropinDRUG

Menopur is used for controlled ovarian stimulation (COH)

Also known as: Menopur
Mono-menotropin protocol
Recominant Follicle Stimulating Hormone (rFSH)DRUG

Gonal-f is used for controlled ovarian stimulation (COH)

Also known as: Gonal-f
rFSH protocol

Eligibility Criteria

Age21 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF in an attempt to achieve pregnancy.
  • Day 2-4 Follicle Stimulating Hormone (FSH) \< 10 IU/ml, LH\< 12 IU/ml, and estradiol \<50 pg/ml on day 2-4 of menstrual cycle
  • Antimullerian Hormone \> 1.5
  • Between 10 and 20 basal antral follicles on day 2-4 of the menstrual cycle
  • Body weight \>50 kg, with BMI \> 18 and \< 32 kg/m2

You may not qualify if:

  • Smokers
  • Polycystic ovarian disease
  • Endometriosis greater than Stage I
  • Testicular aspirated sperm
  • Preimplantation Genetic Diagnosis (PGD) for single gene disorder
  • Preimplantation Genetic Screening (PGS) banking cycles
  • Donor Egg Cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Menotropinsfollitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Officials

  • Michael J Glassner, MD

    Main Line Fertility

    PRINCIPAL INVESTIGATOR

  • Sharon H Anderson, PhD

    Main Line Fertility

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 16, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

US(1)