ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 398 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility (ICSI/IVF-NSMI)

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: NCT03298633
Recruitment Status : Not yet recruiting
First Posted : October 2, 2017
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
International Peace Maternity and Child Health Hospital
Women's Hospital School Of Medicine Zhejiang University
Sixth Affiliated Hospital, Sun Yat-sen University
The First Affiliated Hospital of Kunming Medical College
Haidian Maternal and Child Health Hospital
Information provided by (Responsible Party):
Jie Qiao, Peking University Third Hospital

Brief Summary:
A multicenter, parallel-controlled(1:1 treatment ratio), double-blinded, randomized clinical trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among couples with no-severe male-factor infertility in China.

Condition or disease Intervention/treatment Phase
Male Infertility Other: ICSI Other: Conventional IVF Not Applicable

Detailed Description:
A multicenter, large-scale, randomized controlled clinical trial will enroll 2,346 couples with non-severe male infertility undergoing their first or second cycle of IVF or ICSI. The study will recruit participants from 6 Reproductive Medical Centers across mainland China.The participation in this study will be approximately 2 years with a total of 7 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to two groups at a ratio of 1:1- ICSI protocol, and conventional IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients that have provided informed consent will be randomized to either ICSI or conventional IVF. Randomization and allocation of patients to study groups will be performed on the day of oocyte retrieval. Stratified permuted block randomization will be centrally controlled by administrative staffs in the trial center, who are not involved in the treatment procedure. When there is an eligible participant to be enrolled into the study, nurses from the specific site will login the trial system to get allocation of patients according to a computer-generated randomization list in a 1:1 ratio, with a variable block size of 2, 4 or 8 and stratified by center.
Masking: Double (Participant, Care Provider)
Masking Description: This study will be blinded to participants and clinicians who perform embryo transfer.
Primary Purpose: Treatment
Official Title: Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: Intracytoplasmic Sperm Injection
On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in group A will undergone Intracytoplasmic Sperm Injection (ICSI) procedure, other standard assisted reproductive treatments are similar and parallel between two groups.
Other: ICSI
All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo routine ICSI procedure according to the result of randomization in each study site.

Active Comparator: Conventional IVF
On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in this group will undergone Conventional In Vitro Fertilization (IVF) procedure, other standard assisted reproductive treatments are similar and parallel between two groups.
Other: Conventional IVF
All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo conventional IVF procedure according to the result of randomization in each study site.




Primary Outcome Measures :
  1. Ongoing pregnancy leading to live birth after the first cycle with embryo transfer [ Time Frame: After 28 weeks of gestation ]
    A delivery of one or more living infants (≥28 weeks gestation or birth weight more than 1,000g).


Secondary Outcome Measures :
  1. Fertilization [ Time Frame: 16-20 hours after oocyte retrieval ]
    Number of zygotes with 2 PN (per oocyte retrieved and per oocyte inseminated/injected).

  2. Total fertilization failure [ Time Frame: 72 hours after oocyte retrieval ]
    No oocyte formed 2 PN in this given cycle.

  3. Available embryo [ Time Frame: 72 hours after oocyte retrieval ]
    Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation.

  4. Good quality embryo [ Time Frame: 72 hours after oocyte retrieval ]
    Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation.

  5. Implantation [ Time Frame: 28 days after embryo transfer ]
    Number of gestational sacs observed per embryo transferred.

  6. Clinical pregnancy [ Time Frame: 7 weeks after embryo transfer ]
    One or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 7 weeks after embryo transfer (including clinically documented ectopic pregnancy).

  7. Multiple pregnancy [ Time Frame: 7 weeks after embryo transfer ]
    Pregnancy with two or more gestational sacs or positive heart beats at 7 weeks of gestation.

  8. Ongoing pregnancy [ Time Frame: 12 weeks after embryo transfer ]
    Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.

  9. Moderate/severe ovarian hyperstimulation syndrome (OHSS) [ Time Frame: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assessed about 14-16 days. ]
    exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate, or severe according to the degree of abdominal distention, ovarian Enlargement, and respiratory, hemodynamic, and metabolic complications.

  10. Miscarriage [ Time Frame: 28 weeks of gestation ]
    Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age.

  11. Ectopic pregnancy [ Time Frame: 7 weeks of gestation ]
    Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.

  12. Gestational diabetes mellitus (GDM) [ Time Frame: 24-37 weeks of pregnancy ]
  13. Hypertensive disorders of pregnancy [ Time Frame: 28-37 weeks of pregnancy ]
    Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.

  14. Antepartum haemorrhage [ Time Frame: 28-37 weeks of pregnancy ]
    Including placenta previa, placenta accreta and unexplained.

  15. Preterm birth [ Time Frame: 28-37 weeks of pregnancy ]
    Birth of a fetus delivered after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy.

  16. Birth weight [ Time Frame: Within 2 weeks after live birth ]
    Including low birth weight (defined as weight < 2500 gm at birth), very low birth weight (defined as < 1500 gm at birth), high birth weight (defined as >4000 gm at birth) and very high birth weight (defined as >4500 gm at birth).

  17. Large for gestational age [ Time Frame: Within 2 weeks after live birth ]
    Birth weight >90th centile for gestation, based on standardised ethnicity based charts.

  18. Small for gestational age [ Time Frame: Within 2 weeks after live birth ]
    Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.

  19. Congenital anomaly [ Time Frame: Within 2 weeks after live birth ]
    Any congenital anomaly will be included.

  20. Perinatal mortality [ Time Frame: Within 2 weeks after live birth ]
    Fetal or neonatal death occurring during late pregnancy (at 28 completed weeks of gestational age and later), during childbirth, or up to seven completed days after birth.



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.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertile couples scheduled for their first or second IVF/ICSI cycle.
  • Men with non-severe male infertility: Sperm concentration 5,000,000-15,000,000/ml or sperm with progressive motility (type A+B) 10-32%.
  • Women received either gonadotrophin-releasing hormone agonist protocol or gonadotrophin-releasing hormone antagonist protocol as their controlled ovarian hyperstimulation treatment.
  • Informed consent obtained.

Exclusion Criteria:

  • Couple with contraindication for IVF or ICSI.
  • Couples receiving donor sperm or donor eggs.
  • Couples undergoing PGD and PGS.
  • Sperm concentration with progressive motility used for insemination <100,000/ml on the day of oocyte retrieval.
  • Women with 0 oocytes after oocyte retrieval.
  • Using frozen semen.
  • Poor fertilization in previous cycle (≤ 25%).

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): NCT03298633


Contacts
Contact: Danni Zheng, Bachelor +86-010-82266630 danilinda136@163.com
Contact: Rui Yang, M.D. +86-010-82265080 yrjeff@126.com

Sponsors and Collaborators
Jie Qiao
International Peace Maternity and Child Health Hospital
Women's Hospital School Of Medicine Zhejiang University
Sixth Affiliated Hospital, Sun Yat-sen University
The First Affiliated Hospital of Kunming Medical College
Haidian Maternal and Child Health Hospital
Investigators
Study Director: Jie Qiao, M.D. Peking University Third Hospital

Responsible Party: Jie Qiao, President, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03298633     History of Changes
Other Study ID Numbers: ICSI/IVF-NSMI
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jie Qiao, Peking University Third Hospital:
Male infertility
In vitro fertilization
Intracytoplasmic sperm injection

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs