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Mono-menotropins Versus rFSH Protocol on Embryo Quality

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ClinicalTrials.gov Identifier: NCT02418533
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Main Line Fertility Center

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.


Condition or disease Intervention/treatment Phase
Infertility Fertility Drug: menotropin Drug: Recominant Follicle Stimulating Hormone (rFSH) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial to Compare Mono-menotropins Protocol for Controlled Ovarian Stimulation (COS) Versus Recombinant Follicle Stimulating Hormone (rFSH) Protocol on Embryo Quality Parameters in IVF Patients
Study Start Date : March 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Menotropins

Arm Intervention/treatment
Experimental: Mono-menotropin protocol
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
Menopur is used for controlled ovarian stimulation (COH)
Other Name: Menopur

Experimental: rFSH protocol
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)
Gonal-f is used for controlled ovarian stimulation (COH)
Other Name: Gonal-f




Primary Outcome Measures :
  1. Embryo Quality [ Time Frame: Embryo quality will be assessed on day 3, 5 and 6 of culture ]
    Embryo quality parameters include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse parameters, and chromosomal aneuploidy rates after PGS.



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Ages Eligible for Study:   21 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418533


Locations
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United States, Pennsylvania
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
Main Line Fertility Center
Investigators
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Principal Investigator: Michael J Glassner, MD Main Line Fertility
Study Director: Sharon H Anderson, PhD Main Line Fertility
Additional Information:
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Responsible Party: Main Line Fertility Center
ClinicalTrials.gov Identifier: NCT02418533    
Other Study ID Numbers: MLFC-004
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Keywords provided by Main Line Fertility Center:
infertility
in vitro fertilization
fertility
preimplantation genetic screening
embryo
PGS
Eeva
IVF
Additional relevant MeSH terms:
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Infertility
Menotropins
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents