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NCT Number: NCT03298633

ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility

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

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

ICSI

Other

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.

Conventional IVF

Other

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 outcomes

  1. Ongoing pregnancy leading to live birth after the first cycle with embryo transfer

    Time frame: After 22 weeks of gestation

    A delivery of one or more living infants (≥22 weeks gestation or birth weight more than 1,000g).

Secondary outcomes

  1. Fertilization

    Time frame: 16-20 hours after oocyte retrieval

    Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).

  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: 22 weeks of gestation

    Spontaneous loss of an intra-uterine pregnancy prior to 22 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 6 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.

  21. Neonatal mortality

    Time frame: Within 6 weeks after live birth

    death of a live born baby within 28 days of birth

Sponsors and collaborators

Lead sponsor

Jie Qiao

Other

Collaborators

  • Beijing Haidian Maternal and Child Health Hospital
  • First Affiliated Hospital of Kunming Medical University
  • General Hospital of Ningxia Medical University
  • International Peace Maternity and Child Health Hospital
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • The First Affiliated Hospital of Anhui Medical University
  • The Second Hospital of Hebei Medical University
  • The Third Affiliated Hospital of Guangzhou Medical University
  • Women's Hospital School Of Medicine Zhejiang University

Registry information

Official study title

Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial

Acronym: ICSI/IVF-NSMI

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2017
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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