ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility (ICSI/IVF-NSMI)
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|ClinicalTrials.gov Identifier: NCT03298633|
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Male Infertility||Other: ICSI Other: Conventional IVF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2346 participants|
|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:||None (Open Label)|
|Masking Description:||The blinding method in out study is open-label in general. However, in order to avoid psychological effect for participants and unexpected drop-off, the trial is designed to inform participants their insemination method on the day of fresh embryo transfer or the day of embryo freezing. Prior to this, randomization will be strictly performed and keep secret to participants and clinicians.|
|Official Title:||Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial|
|Actual Study Start Date :||April 4, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||December 2020|
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.
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.
- 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).
- Fertilization [ Time Frame: 16-20 hours after oocyte retrieval ]Number of zygotes with 2 PN (per oocyte retrieved and per women randomized).
- Total fertilization failure [ Time Frame: 72 hours after oocyte retrieval ]No oocyte formed 2 PN in this given cycle.
- Available embryo [ Time Frame: 72 hours after oocyte retrieval ]Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation.
- 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.
- Implantation [ Time Frame: 28 days after embryo transfer ]Number of gestational sacs observed per embryo transferred.
- 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).
- 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.
- Ongoing pregnancy [ Time Frame: 12 weeks after embryo transfer ]Presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.
- 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.
- Miscarriage [ Time Frame: 22 weeks of gestation ]Spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age.
- Ectopic pregnancy [ Time Frame: 7 weeks of gestation ]Implantation takes place outside the uterine cavity, confirmed by sonography or laparoscopy.
- Gestational diabetes mellitus (GDM) [ Time Frame: 24-37 weeks of pregnancy ]
- Hypertensive disorders of pregnancy [ Time Frame: 28-37 weeks of pregnancy ]Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia.
- Antepartum haemorrhage [ Time Frame: 28-37 weeks of pregnancy ]Including placenta previa, placenta accreta and unexplained.
- 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.
- 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).
- Large for gestational age [ Time Frame: Within 2 weeks after live birth ]Birth weight >90th centile for gestation, based on standardised ethnicity based charts.
- 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.
- Congenital anomaly [ Time Frame: Within 2 weeks after live birth ]Any congenital anomaly will be included.
- 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.
- Neonatal mortality [ Time Frame: Within 6 weeks after live birth ]death of a live born baby within 28 days of birth
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
|Contact: Danni Zheng, Bachelorfirstname.lastname@example.org|
|Contact: Rui Yang, M.D.||+email@example.com|
|First Affiliated Hospital of Anhui Medical University||Not yet recruiting|
|Hefei, Anhui, China, 230022|
|Contact: Yunxia Cao, M.D.|
|Peking University third Hospital||Recruiting|
|Beijing, Beijing, China, 100191|
|Contact: Jie Qiao, MD, PHD 86-10-82266699|
|Principal Investigator: Jie Qiao, MD, PHD|
|Haidian Maternal and Child Health Hospital||Recruiting|
|Beijing, Beijing, China|
|Contact: Hui Chun Wang|
|The Third Affiliated Hospital of Guangzhou Medical University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510150|
|Contact: Jianqiao Liu, M.D.|
|The Sixth Affiliated Hospital of Sun Yat-Sen University||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: Xiaoyan Liang, M.D.|
|The Second Hospital of Hebei Medical University||Not yet recruiting|
|Shijiazhuang, Hebei, China, 050000|
|Contact: Guimin Hao, M.D.|
|General Hospital of Ningxia Medical University||Not yet recruiting|
|Yinchuan, Ningxia, China, 750004|
|Contact: Junli Zhao, M.D.|
|International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University||Recruiting|
|Shanghai, Shanghai, China|
|Contact: He-Feng Huang, M.D.|
|First Affiliated Hospital of Kunming Medical University||Recruiting|
|Kunming, Yunnan, China|
|Contact: Li Tang, M.D.|
|Women's Hospital of Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China|
|Contact: Yi-Min Zhu, M.D.|
|Study Director:||Jie Qiao, M.D.||Peking University Third Hospital|