Infertility, Female Clinical Trial
— ICSIOfficial title:
The Role of Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Maternal Age Above 39
Verified date | July 2020 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The use of Intracytoplasmic sperm injection (ICSI) has increased in the last decades regardless of the cause of infertility. Despite the increased use there is no clear evidence that ICIS is more effective than conventional in vitro fertilization (IVF) for non-male factor infertility. The investigators therefore aim to perform a prospective randomized controlled study to compare between ICSI and conventional IVF in women between 39 to 44 years of age with non-male factor infertility.
Status | Completed |
Enrollment | 69 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 39 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Women between 39 to 44 years of age undergoing IVF treatments for non-male factor infertility. Exclusion Criteria: - Women undergoing IVF treatments for male factor infertility. - Cases where PGD is planned. - Women with a BMI above 40. - Women younger then 39 years of age or older then 44 years of age. - Women with a rate of fertilization bellow 50% in previous IVF cycles. |
Country | Name | City | State |
---|---|---|---|
Israel | IVF Unit, Sheba medical Center | Tel HaShomer |
Lead Sponsor | Collaborator |
---|---|
Dr. Tal Miller-Elkan |
Israel,
Bhattacharya S, Hamilton MP, Shaaban M, Khalaf Y, Seddler M, Ghobara T, Braude P, Kennedy R, Rutherford A, Hartshorne G, Templeton A. Conventional in-vitro fertilisation versus intracytoplasmic sperm injection for the treatment of non-male-factor infertility: a randomised controlled trial. Lancet. 2001 Jun 30;357(9274):2075-9. — View Citation
Boulet SL, Mehta A, Kissin DM, Warner L, Kawwass JF, Jamieson DJ. Trends in use of and reproductive outcomes associated with intracytoplasmic sperm injection. JAMA. 2015 Jan 20;313(3):255-63. doi: 10.1001/jama.2014.17985. — View Citation
Check JH, Yuan W, Garberi-Levito MC, Swenson K, McMonagle K. Effect of method of oocyte fertilization on fertilization, pregnancy and implantation rates in women with unexplained infertility. Clin Exp Obstet Gynecol. 2011;38(3):203-5. — View Citation
Fishel S, Aslam I, Lisi F, Rinaldi L, Timson J, Jacobson M, Gobetz L, Green S, Campbell A, Lisi R. Should ICSI be the treatment of choice for all cases of in-vitro conception? Hum Reprod. 2000 Jun;15(6):1278-83. — View Citation
Korkmaz C, Tekin YB, Sakinci M, Ercan CM. Effects of maternal ageing on ICSI outcomes and embryo development in relation to oocytes morphological characteristics of birefringent structures. Zygote. 2015 Aug;23(4):550-5. doi: 10.1017/S0967199414000197. Epub 2014 May 29. — View Citation
Luna M, Bigelow C, Duke M, Ruman J, Sandler B, Grunfeld L, Copperman AB. Should ICSI be recommended routinely in patients with four or fewer oocytes retrieved? J Assist Reprod Genet. 2011 Sep;28(10):911-5. doi: 10.1007/s10815-011-9614-9. Epub 2011 Jul 27. — View Citation
Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. — View Citation
Tannus S, Son WY, Gilman A, Younes G, Shavit T, Dahan MH. The role of intracytoplasmic sperm injection in non-male factor infertility in advanced maternal age. Hum Reprod. 2017 Jan;32(1):119-124. Epub 2016 Nov 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fertilization rate | The rate of fertilized oocytes | 1 day | |
Secondary | Embryos | Number of embryos day 2/3 | 3-4 day | |
Secondary | Top quality embryos | Number of top quality embryos day 2/3. Embryos will be defined as top quality if they will have four cells on Day 2 and/or 7 or 8 cells on Day 3, contain <20% fragmentation, and exhibited no apparent morphological abnormalities. | 3-4 days | |
Secondary | Pregnancy | Pregnancy is defined as positive ßhCG blood test 11-14 days after embryo transfer. | Approximately 2 weeks | |
Secondary | Clinical pregnancy | Clinical pregnancy is defined as gestational sac seen on vaginal ultrasound scan by 6 weeks gestation. | Approximately 6 weeks | |
Secondary | Pregnancy above 8 weeks gestation | Pregnancy above 8 weeks gestation with the appreance of a fetal pulse | Approximately 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05969574 -
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
|
||
Recruiting |
NCT05358483 -
PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Completed |
NCT03177538 -
Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders
|
Phase 4 | |
Completed |
NCT03638856 -
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
|
N/A | |
Completed |
NCT04052464 -
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
|
||
Withdrawn |
NCT04753736 -
Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC
|
N/A | |
Completed |
NCT03349905 -
Deferred Versus Fresh Embryo Transfers
|
N/A | |
Completed |
NCT05076981 -
Progesterone Levels During Ovulation and Luteal Phase
|
||
Completed |
NCT04096027 -
Cabergoline Before or After Oocyte Collection for Follicular Resolution
|
Phase 4 | |
Recruiting |
NCT05980091 -
Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.
|
Phase 1 | |
Terminated |
NCT01933633 -
Improved Fertility After Exercise in Overweight/Obese Women
|
N/A | |
Terminated |
NCT01202643 -
Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF
|
Phase 1/Phase 2 | |
Completed |
NCT01202656 -
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
|
Phase 1/Phase 2 | |
Completed |
NCT01408615 -
A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
|
||
Enrolling by invitation |
NCT05698550 -
The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET
|
Phase 3 | |
Not yet recruiting |
NCT03910582 -
Personalized FET in RIF Patients With Displaced Dating
|
N/A | |
Completed |
NCT05440019 -
Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
|
||
Completed |
NCT05130125 -
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer
|