Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483298
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief Summary:
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

Condition or disease Intervention/treatment
Infertility Other: ICSI

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 23, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Blastulation Rate of testicular vs. ejaculated sperm after ICSI [ Time Frame: 1 week post ICSI ]
    # blast per 2 pronuclei in each group


Secondary Outcome Measures :
  1. Fertilization Rate [ Time Frame: 24 hrs post ICSI ]
    # fertilized per M2 in each group

  2. Aneuploidy Rate [ Time Frame: approximately 2 weeks post trophectoderm biopsy ]
    # abnormal embryos per useable blast in each group

  3. Clinical Pregnancy Rate [ Time Frame: approximately 2 weeks post pregnancy test ]
    defined by presence of gestational sac and yolk sac in uterus on ultrasound


Biospecimen Retention:   Samples With DNA
Serum obtained from male patient


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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
Criteria

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

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): NCT03483298


Contacts
Layout table for location contacts
Contact: Christine V Whitehead, BSN,RN 973-656-2841 clinicalresearchteam@rmanj.com
Contact: Talia Metzgar, RN 973-656-2841 clinicalresearchteam@rmanj.com

Locations
Layout table for location information
United States, New Jersey
IVI RMA New Jersey Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Christine V Whitehead, BSN,RN    973-656-2841    clinicalresearchteam@rmanj.com   
Contact: Talia Metzgar, RN    973-656-2841    clinicalresearchteam@rmanj.com   
Principal Investigator: James Hotaling, MD         
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Layout table for investigator information
Principal Investigator: James Hotaling, MD IVI RMA
Publications:

Layout table for additonal information
Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT03483298    
Other Study ID Numbers: RMA-2018-04
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility