The Effectiveness and Safety of the Prolonged Down-regulation Protocol for Controlled Ovarian Hyperstimulation
Status:
Unknown status
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
Since the first "tube baby", Louise Brown, was born in the United Kingdom in 1978, many
infertile couples have been benefitted from in vitro fertilization and embryo transfer
(IVF-ET) and intracytoplasmic sperm injection (ICSI). Although a late starter, China is
developing rapidly in ART and playing a more and more important role in the area of
reproductive medicine.
In spite of the continuous development in ART, so far, the overall success rate of IVF/ICSI
is still hovering around 25-40%. There are many factors influencing the success rate of
IVF/ICSI. Among them, an appropriate controlled ovarian hyperstimulation (COH) protocol is
directly associated with the number of oocyte retrieved, as well as the number and quality of
embryos, which exert an important influence on the success rate of IVF/ICSI. The luteal phase
pituitary down-regulation protocol is one of the most widely used COH protocols in clinical
practice, particularly in China. Though effective, it may lead to an increased incidence of
ovarian hyperstimulation syndrome (OHSS), as well as a negative impact on endometrial
receptivity. The coping strategy is to freeze all the embryos and transfer in the next cycle.
Though avoiding the above mentioned adverse effects, such strategy increases the time to
pregnancy (TTP) and therefore results in certain psychological and economic burdens for
infertile couples.
In recent years, some Chinese researches applied the early follicular full-dose
down-regulation protocol that is always performed to women with endometriosis to a more
general IVF/ICSI population and found a clinical pregnancy rate of 64% in the fresh embryo
transfer cycle, much higher than that of the luteal phase down-regulation protocol.
Furthermore, since this protocol decrease the risk of progesterone elevation on hCG day, it
increases the fresh embryo transfer rate and shortens TTP.
Given most studies regarding the effectiveness and safety of the early follicular phase
full-dose down-regulation protocol are retrospective studies, the results may be biased by
several confounding factors. Therefore, we would like to conduct a multicenter, randomized
controlled trial to compare the pregnancy outcome and safety indicators between the early
follicular phase full-dose down-regulation protocol and the luteal phase down-regulation
protocol.
Phase:
Phase 4
Details
Lead Sponsor:
Peking University People's Hospital
Collaborators:
First Affiliated Hospital of Guangxi Medical University First Affiliated Hospital of Wenzhou Medical University Guangxi Maternal and Child Health Hospital Henan Provincial Hospital Henan Provincial People's Hospital Jiangxi Maternal and Child Health Hospital Peking University First Hospital Second Affiliated Hospital of Wenzhou Medical University Second Affiliated Hospital of Zhengzhou University Shanxi Provincial Maternity and Children's Hospital The First Affiliated Hospital of Zhengzhou University The Second Hospital of Hebei Medical University West China Hospital Xinjiang Jiayin Hospital Yinchuan Municipal Maternal and Child Health Hospital