Fertility Clinical Trial
Official title:
A Randomized Double Blinded Controlled Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment
In vitro fertilization (IVF) treatment is now commonly used to treat infertile couples.
During IVF treatment, oocytes and sperm are routinely incubated overnight and this may lead
to suboptimal culture conditions because of increased reactive oxygen species (ROS) produced
by sperm in the standard incubation. High levels of ROS can adversely affect the quality of
the embryos, result in hardening of the zona pellucida and impair the implantation capacity
of embryos. Studies shows successful fertilization of an oocyte occurs 20mins after the
gametes are put together. Sperm can penetrate through the cumulus cells within 15min, and
80% of oocytes can be fertilized when they are exposed to a large number of spermatozoa
within 1hr. As an attempt to avoid possible detrimental effects on the oocytes from long
exposure to sperm, the brief incubation insemination protocol was developed. It implies that
prolonged incubation of oocytes and sperm may not be necessary and may even be harmful. Some
reports suggest that a sperm-oocyte exposure time of 1-6 h improves IVF outcomes. However,
other studies report no such advantage with a short insemination time .
A recent meta-analysis shows brief incubation of gametes was associated with significantly
higher rates of clinical pregnancy , ongoing pregnancy and higher rate of implantation than
standard incubation. But the rates of normal fertilization, good quality embryos and
polyspermy were not significantly different compared with standard incubation. In a Cochrane
meta-analysis, eight RCTs with 733 women were included, and showed similar results. But it
only reported clinical pregnancy rate and ongoing pregnancy rate which were significantly
higher in brief incubation group than standard incubation. However, the live birth rate,
which is the important outcome parameter, was not reported in all these studies. It is
uncertain whether brief incubation improves the life birth rate compared with standard
incubation.
The aim of this randomized double blinded study is to compare the live birth rate of IVF
treatment following brief incubation of oocytes and sperm versus standard incubation. The
hypothesis is that a brief incubation improves the live birth rate of IVF treatment.
Status | Not yet recruiting |
Enrollment | 280 |
Est. completion date | September 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 42 Years |
Eligibility |
Inclusion Criteria: - Women under 42 years of age - Any indications for conventional insemination such as tubal, endometriosis, unexplained and mild male factor - Written informed consent Exclusion Criteria: - Women using donor eggs/donor sperm - Women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram - Women with hydrosalpinges shown on scanning and not corrected treated - Husband with severe oligospermia or azospermia or teraspermia (nomal morphology<5%) - Previous fertilization failure for conventional insemination in the past (fertilization rate<30%) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shanghai first Maternity and Infant health hospital, Tong Ji University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai First Maternity and Infant Hospital | The University of Hong Kong |
China,
Barraud-Lange V, Sifer C, Pocaté K, Ziyyat A, Martin-Pont B, Porcher R, Hugues JN, Wolf JP. Short gamete co-incubation during in vitro fertilization decreases the fertilization rate and does not improve embryo quality: a prospective auto controlled study. — View Citation
Chen C, Kattera S. Rescue ICSI of oocytes that failed to extrude the second polar body 6 h post-insemination in conventional IVF. Hum Reprod. 2003 Oct;18(10):2118-21. — View Citation
Dirnfeld M, Bider D, Koifman M, Calderon I, Abramovici H. Shortened exposure of oocytes to spermatozoa improves in-vitro fertilization outcome: a prospective, randomized, controlled study. Hum Reprod. 1999 Oct;14(10):2562-4. — View Citation
Dirnfeld M, Shiloh H, Bider D, Harari E, Koifman M, Lahav-Baratz S, Abramovici H. A prospective randomized controlled study of the effect of short coincubation of gametes during insemination on zona pellucida thickness. Gynecol Endocrinol. 2003 Oct;17(5): — View Citation
Gianaroli L, Cristina Magli M, Ferraretti AP, Fiorentino A, Tosti E, Panzella S, Dale B. Reducing the time of sperm-oocyte interaction in human in-vitro fertilization improves the implantation rate. Hum Reprod. 1996 Jan;11(1):166-71. — View Citation
Gianaroli L, Fiorentino A, Magli MC, Ferraretti AP, Montanaro N. Prolonged sperm-oocyte exposure and high sperm concentration affect human embryo viability and pregnancy rate. Hum Reprod. 1996 Nov;11(11):2507-11. — View Citation
Huang Z, Li J, Wang L, Yan J, Shi Y, Li S. Brief co-incubation of sperm and oocytes for in vitro fertilization techniques. Cochrane Database Syst Rev. 2013 Apr 30;4:CD009391. doi: 10.1002/14651858.CD009391.pub2. Review. — View Citation
Kattera S, Chen C. Short coincubation of gametes in in vitro fertilization improves implantation and pregnancy rates: a prospective, randomized, controlled study. Fertil Steril. 2003 Oct;80(4):1017-21. — View Citation
Lundqvist M, Johansson U, Lundkvist O, Milton K, Westin C, Simberg N. Reducing the time of co-incubation of gametes in human in-vitro fertilization has no beneficial effects. Reprod Biomed Online. 2001;3(1):21-24. — View Citation
Waldenstrom U, Hamberger L, Nilsson L, Ryding M. Short-time sperm-egg exposure to prevent zona hardening. J Assist Reprod Genet 1993;10:190
Wassarman PM. Fertilization in mammals. Sci Am. 1988 Dec;259(6):78-84. Review. — View Citation
Zhang XD, Liu JX, Liu WW, Gao Y, Han W, Xiong S, Wu LH, Huang GN. Time of insemination culture and outcomes of in vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2013 Nov-Dec;19(6):685-95. doi: 10.1093/humupd/dmt036. Epub 2013 Aug 2. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | live birth rate. | Number of live birth per transfer cycle | 1 year | No |
Secondary | Miscarriage rate | 1 year | No | |
Secondary | Clinical pregnancy rates | 1 year | No | |
Secondary | Normal fertilization rate | 1 year | No | |
Secondary | polyspermy rate(>=3PN) | 1 year | Yes | |
Secondary | Cleavage rate | 1 year | Yes | |
Secondary | Implantation rate | 1 year | No |
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