InfertilityNCT02418533
Mono-menotropins Versus rFSH Protocol on Embryo Quality
A study testing menotropin and Recominant Follicle Stimulating Hormone (rFSH) in people with Infertility and Fertility, run by Main Line Fertility Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Fertility
- What is being tested?
- menotropin and Recominant Follicle Stimulating Hormone (rFSH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010
About this study
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
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.
Read the detailed description
This proposed study is a single-center, prospective, randomized experimental design.
One-hundred women between the ages of 21 to 38 (inclusive) pursuing IVF treatment for infertility and preimplantation genetic screening (PGS).
Pre-medication All study patients will take oral contraception pills (OCP) starting between day 2-4 of the menstrual cycle before controlled ovarian stimulation (COS) is started for IVF, and they are continued for 21 days. Cycle preparation using an oral contraceptive pill is thought to be important in improving follicular homogeneity.
Randomization Randomization of patients into the Stimulation Group 1 (Mono-Menotropin Protocol) or Stimulation Group 2 (rFSH) will occur at OCP start using a computerized randomization program.
Ovarian Stimulation Stimulation Group 1: Mono-Menotropin Protocol Fifty patients will undergo the standard of care COS for IVF using Menopur (Ferring, Parsippany, New Jersey (NJ) USA) 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.
Stimulation Group 2: rFSH Protocol Fifty patients will undergo the standard of care controlled ovarian stimulation (COS) for IVF using Gonal-f (EMD Serono, USA) protocol. Patients will receive 300 IU of Gonal-f 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.
Menopur and Gonal-f are widely used in controlled ovarian stimulation cycles for the development of multiple follicles in assisted reproductive technology (ART) programs.
Luteinizing Hormone (LH)-surge Suppression Gonadotropin Releasing Hormone (GnRH) antagonist will be used to suppress endogenous pituitary LH for the prevention of premature LH surges. Patients will receive 0.25 mg/day of Ganirelix Acetate or Cetroelix Acetate when follicle size reaches 12 mm and will continue up to and including day of hCG trigger.
HCG Trigger Human chorionic gonadotropin (hCG) will be used intramuscularly (IM) in both stimulation groups to induce oocyte maturation 36 hours prior to the oocyte retrieval procedure
Cycle Monitoring Cycles will be monitored with follicular ultrasound measurements and serum estradiol concentrations throughout ovarian stimulation. HCG will be given IM when at least three follicles reach a diameter of ≥17 mm. Egg retrieval will be conducted by transvaginal ultrasound 36 h after hCG administration.
Insemination All mature oocytes will have intracytoplasmic sperm injection (ICSI) or standard insemination to achieve fertilization.
Embryo Development Two-pronuclei (2pn) embryos will be placed in the Eeva dish after fertilization check at 16-18 hours post ICSI. To maintain a continuous and uninterrupted imaging process from day 1 through day 3, no media changes or dish removal from the incubator will be permitted. On day 3, imaging will be stopped just before routine embryo grading will be performed according to Society for Assisted Reproductive Technology (SART) standards. Cell number and quality score based on symmetry of cells and percent fragmentation will be recorded. Embryos will be tracked individually. Software will automatically measures cell division timings and provide quantitative information regarding embryo development. Embryo grading day 5 will be performed according to standard operating procedure. Blastocysts will be biopsied on day 5 or 6. Biopsies will be sent to a genetics laboratory (Reprogenetics, New Jersey) for aCGH euploidy testing. Biopsied blastocysts will be vitrified for future frozen embryo transfer (FET) cycle/s, in which euploid blastocyst/s with the correct number of chromosomes will be thawed and transferred back to the uterus in an attempt to achieve pregnancy.
Abnormal embryos (aneuploidy embryos with the incorrect number of chromosomes) may be donated to research or discarded.
- Conditions
- Infertility, Fertility
- Being tested
- menotropin, Recominant Follicle Stimulating Hormone (rFSH)
- Keywords
- infertility, in vitro fertilization, fertility, preimplantation genetic screening, embryo, PGS, Eeva, IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menotropinDrug
Also called Menopur
Menopur is used for controlled ovarian stimulation (COH)
Recominant Follicle Stimulating Hormone (rFSH)Drug
Also called Gonal-f
Gonal-f is used for controlled ovarian stimulation (COH)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Recominant Follicle Stimulating Hormone (rFSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo Quality
Embryo quality parameters include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse parameters, and chromosomal aneuploidy rates after PGS.
Measured: Embryo quality will be assessed on day 3, 5 and 6 of culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Glassner, MD, Principal investigator, Main Line FertilitySharon H Anderson, PhD, Study director, Main Line Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418533
- Sponsor's protocol ID
- MLFC-004
- Status last verified
- Aug 2020
- First submitted
- 31 Mar 2015
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02418533
- Acronym / sponsor ID
- MLFC-004
- Conditions
- Infertility, Fertility
- Keywords
- infertility, in vitro fertilization, fertility, preimplantation genetic screening, embryo, PGS, Eeva, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Main Line Fertility CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposed study is a single-center, prospective, randomized experimental design.
One-hundred women between the ages of 21 to 38 (inclusive) pursuing IVF treatment for infertility and preimplantation genetic screening (PGS).
Pre-medication All study patients will take oral contraception pills (OCP) starting between day 2-4 of the menstrual cycle before controlled ovarian stimulation (COS) is started for IVF, and they are continued for 21 days. Cycle preparation using an oral contraceptive pill is thought to be important in improving follicular homogeneity.
Randomization Randomization of patients into the Stimulation Group 1 (Mono-Menotropin Protocol) or Stimulation Group 2 (rFSH) will occur at OCP start using a computerized randomization program.
Ovarian Stimulation Stimulation Group 1: Mono-Menotropin Protocol Fifty patients will undergo the standard of care COS for IVF using Menopur (Ferring, Parsippany, New Jersey (NJ) USA) 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.
Stimulation Group 2: rFSH Protocol Fifty patients will undergo the standard of care controlled ovarian stimulation (COS) for IVF using Gonal-f (EMD Serono, USA) protocol. Patients will receive 300 IU of Gonal-f 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.
Menopur and Gonal-f are widely used in controlled ovarian stimulation cycles for the development of multiple follicles in assisted reproductive technology (ART) programs.
Luteinizing Hormone (LH)-surge Suppression Gonadotropin Releasing Hormone (GnRH) antagonist will be used to suppress endogenous pituitary LH for the prevention of premature LH surges. Patients will receive 0.25 mg/day of Ganirelix Acetate or Cetroelix Acetate when follicle size reaches 12 mm and will continue up to and including day of hCG trigger.
HCG Trigger Human chorionic gonadotropin (hCG) will be used intramuscularly (IM) in both stimulation groups to induce oocyte maturation 36 hours prior to the oocyte retrieval procedure
Cycle Monitoring Cycles will be monitored with follicular ultrasound measurements and serum estradiol concentrations throughout ovarian stimulation. HCG will be given IM when at least three follicles reach a diameter of ≥17 mm. Egg retrieval will be conducted by transvaginal ultrasound 36 h after hCG administration.
Insemination All mature oocytes will have intracytoplasmic sperm injection (ICSI) or standard insemination to achieve fertilization.
Embryo Development Two-pronuclei (2pn) embryos will be placed in the Eeva dish after fertilization check at 16-18 hours post ICSI. To maintain a continuous and uninterrupted imaging process from day 1 through day 3, no media changes or dish removal from the incubator will be permitted. On day 3, imaging will be stopped just before routine embryo grading will be performed according to Society for Assisted Reproductive Technology (SART) standards. Cell number and quality score based on symmetry of cells and percent fragmentation will be recorded. Embryos will be tracked individually. Software will automatically measures cell division timings and provide quantitative information regarding embryo development. Embryo grading day 5 will be performed according to standard operating procedure. Blastocysts will be biopsied on day 5 or 6. Biopsies will be sent to a genetics laboratory (Reprogenetics, New Jersey) for aCGH euploidy testing. Biopsied blastocysts will be vitrified for future frozen embryo transfer (FET) cycle/s, in which euploid blastocyst/s with the correct number of chromosomes will be thawed and transferred back to the uterus in an attempt to achieve pregnancy.
Abnormal embryos (aneuploidy embryos with the incorrect number of chromosomes) may be donated to research or discarded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mono-menotropin protocol | Experimental | Drug: menotropinStimulation 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. |
| rFSH protocol | Experimental | Drug: Recominant Follicle Stimulating Hormone (rFSH)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. |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Smokers
- Polycystic ovarian disease
- Endometriosis greater than Stage I
- Testicular aspirated sperm
- Preimplantation Genetic Diagnosis (PGD) for single gene disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| menotropinAlso: MenopurMenopur is used for controlled ovarian stimulation (COH) | Drug | Mono-menotropin protocol |
| Recominant Follicle Stimulating Hormone (rFSH)Also: Gonal-fGonal-f is used for controlled ovarian stimulation (COH) | Drug | rFSH protocol |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Main Line Fertility websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Glassner, MD principal investigator
Main Line Fertility
Sharon H Anderson, PhD study director
Main Line Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing menotropin and Recominant Follicle Stimulating Hormone (rFSH) in people with Infertility and Fertility, run by Main Line Fertility Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo Quality (time frame: Embryo quality will be assessed on day 3, 5 and 6 of culture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.