Split Cohort Trial Comparing IVF Outcomes After the Use of Testicular vs. Ejaculated Sperm for ICSI

January 13, 2022 updated by: Reproductive Medicine Associates of New Jersey

Prospective Split Cohort Trial Comparing in Vitro Fertilization (IVF) Outcomes After the Use of Testicular Versus Ejaculated Sperm for ICSI in Med With Elevated DNA Fragmentation After a Failed IVF Cycle

The primary objective of this study is to determine if there is a difference in in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) outcomes when using testicular sperm versus ejaculated sperm in couples with elevated sperm DNA fragmentation after a failed in vitro fertilization (IVF) cycle

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The experimental design for this study is as follows:

  1. Couples with male partners who will be undergoing a TESA procedure secondary to elevated DNA fragmentation (>25% DFI) as part of their routine IVF treatment will be contacted for possible study participation.
  2. Informed consent will be obtained
  3. The primary investigator will be notified of the couple's participation.
  4. The male partner will cryopreserve an ejaculated semen sample if there is no cryopreserved ejaculated specimen in inventory. The male partner will undergo a surgical sperm retrieval (TESA) and the specimen will be frozen per routine.
  5. Serum will be collected from the male partner and preserved for future analysis.
  6. The cryopreserved pre-TESA ejaculate and TESA specimen will be thawed on the day of oocyte retrieval per protocol. After oocyte retrieval, oocytes will be analyzed per routine and assessed for maturity. The oocytes will be divided into two groups per embryologist discretion. One group will be labeled 'A' and the other will be labeled B.' A random letter generator will create a list of 'A' and 'B's which will be placed in sequentially numbered, sealed envelopes. The envelopes will be opened in sequence according to patient enrollment. The first envelope opened by the embryologist will reveal the letter of the oocyte group that will be inseminated with testicular sperm. The other group will be inseminated with the frozen/ thawed ejaculated sperm. Therefore, half of the oocytes will be inseminated using intracytoplasmic sperm injection (ICSI) with testicular sperm and the other half will be inseminated via ICSI with ejaculated sperm. If there are an odd number of oocytes, the extra oocyte will always belong to group A for simplicity.
  7. If fertilized, the group of zygotes created using testicular sperm will take the group letter that corresponded to the testicular sperm. This will also be true of the zygotes using ejaculated sperm. Both groups of zygotes will be cultured to the blastocyst stage with culture conditions per standard laboratory procedures.
  8. Fertilization and blastulation rates of the two groups will be recorded for each patient.
  9. Each blastocyst will be biopsied for comprehensive chromosome screening (CCS) in routine fashion. Once comprehensive chromosomal screening results are available, if at least one euploid embryo is available, patients will undergo a single embryo transfer in a subsequent menstrual cycle.
  10. Frozen embryo transfer cycles will be performed using either a programmed cycle (exogenous estradiol with subsequent progesterone) or a natural cycle to prepare the endometrium for embryo transfer.
  11. If at least one euploid embryo is available from each group, a second randomization will occur at the time of embryo selection. The embryologist selecting the embryo for transfer will open a second sealed envelope, which contains the letter of the group from which the embryo for transfer should reside. The best quality embryo (per embryologist discretion) from the group corresponding to the letter in this envelope will be selected for transfer. The embryologist selecting the embryo will be blinded as to which group of embryos was created with ejaculated versus testicular sperm. The group from which the embryo selected for transfer was derived will be recorded.
  12. Both the patient and the physician performing the embryo transfer will be blinded with regard to the group from which the embryo selected for transfer derived.
  13. Pregnancy testing and follow up will proceed as per routine.
  14. Approximately 8 weeks post-transfer, each participant will be assigned a cycle outcome (i.e., no pregnancy, miscarriage, ongoing pregnancy). At that time, the study participants can be notified of whether the sperm utilized for ICSI was derived from testicular sperm or ejaculated sperm. This information could be shared via telephone or in-person.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • IVI RMA New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men with Elevated DNA fragmentation noted in ejaculated sperm (>25% DFI according to the American Society of Reproductive Medicine guidelines) and one prior failed IVF cycle

Description

Inclusion Criteria:

  • Willing to comply with all study procedures and be available for the duration of the study
  • Failed at least one IVF cycle (i.e., no live birth)
  • Elevated DNA fragmentation noted in ejaculated sperm (>25% DFI according to the American Society of Reproductive Medicine guidelines)
  • Couple electing single embryo transfer
  • Couples electing comprehensive chromosome screening (CCS) of embryos
  • At least 4 oocytes retrieved in IVF cycle in order to randomize

Exclusion Criteria:

  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
  • Contraindication to IVF
  • Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring detailed embryo genetic analysis)
  • Male partner with azoospermia (<100,000 motile spermatozoa)
  • Male partner with Y-chromosome microdeletion
  • Male partner with any Karyotype other than 46,XY(normal male karyotype)
  • Female partner history of hydrosalpinges or adnexal mass
  • Female partner history of endometrial insufficiency (max endometrial thickness < 7mm)
  • Female partner BMI < 35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
elevated sperm DNA fragmentation
Couples with male partners who will be undergoing a TESA procedure secondary to elevated DNA fragmentation (>25% DFI) as part of their routine IVF treatment will have half of the women's eggs inseminated with ejaculated sperm and the other half with surgically obtained sperm via the ICSI procedure
Other: ICSI
The cryopreserved pre-TESA ejaculate and TESA specimen will be thawed on the day of oocyte retrieval per protocol for ICSI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blastulation Rate of testicular vs. ejaculated sperm after ICSI
Time Frame: 1 week post ICSI
# blast per 2 pronuclei in each group
1 week post ICSI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fertilization Rate
Time Frame: 24 hrs post ICSI
# fertilized per M2 in each group
24 hrs post ICSI
Aneuploidy Rate
Time Frame: approximately 2 weeks post trophectoderm biopsy
# abnormal embryos per useable blast in each group
approximately 2 weeks post trophectoderm biopsy
Clinical Pregnancy Rate
Time Frame: approximately 2 weeks post pregnancy test
defined by presence of gestational sac and yolk sac in uterus on ultrasound
approximately 2 weeks post pregnancy test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Reproductive Medicine Associates of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Phil Cheng, MD, IVI RMA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMA-2018-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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