Effect of Semaglutide on Embryo Quality in Overweight and Obese Patients Undergoing In Vitro Fertilization. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- Number of good quality blastocysts (GQB)
研究概览
简要总结
This is a randomized, controlled clinical trial with a two-sided superiority hypothesis. The study evaluates whether a 12-week pre-treatment with semaglutide prior to ovarian stimulation improves the number of good-quality blastocysts in overweight and obese women undergoing in vitro fertilization (IVF), compared to no pre-treatment.
详细描述
Overweight and obese women (BMI 27-40 kg/m²) aged ≤38 years with adequate ovarian reserve (AMH ≥1 ng/mL or AFC ≥6) will be enrolled. Participants will be randomized in a 1:1 ratio to receive either 12 weeks of semaglutide pre-treatment (intervention group) or no pre-treatment (control group) before undergoing standard ovarian stimulation.
Embryos will be cultured to the blastocyst stage and cryopreserved (freeze-all strategy). In the semaglutide group, embryo transfer will occur after an 8-week washout from the last semaglutide dose.
Primary outcome: number of good-quality blastocysts on day 5. Secondary outcomes: embryo morphokinetics, fertilization rate, number of MII oocytes, number of COCs, total blastocyst formation rate, number of cryopreserved embryos, and pre/post semaglutide changes in weight, BMI, waist circumference, AMH, and AFC.
The study has been designed with a superiority hypothesis to detect a difference of 1.5 good-quality blastocysts between groups, with 80% power and a two-sided alpha of 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≤ 38 years
- •AMH >= 1 ng/mL or AFC >= 6
- •Body mass index (BMI) between 27 kg/m2 and 40 kg/m2
- •Scheduled for IVF with freeze-all strategy
排除标准
- •Severe male factor (sperm concentration <5M/mL)
- •Type 2 diabetes mellitus
- •Prior use of GLP-1 Ras within the past year
- •Uncontrolled thyroid disorders
- •Contraindications to IVF or semaglutide treatment
- •Patients with chronic inflammatory diseases
- •Family history of hereditary or chromosomal diseases
- •Use of glucocorticoids or immunosuppressants
- •Use of medications affecting metabolism or inflammation
研究组 & 干预措施
No pre-treatment
No pre-treatment prior to ovarian stimulation Pre-treatment
干预措施: No pre-treatment (Other)
Semaglutide
Semaglutide 0.25-1.0 mg for 12 weeks prior to ovarian stimulation
干预措施: Semaglutide (Drug)
结局指标
主要结局
Number of good quality blastocysts (GQB)
时间窗: Assessed once per participant, from oocyte retrieval (Day 0) to Day 5 of embryo culture, when embryos reach blastocyst stage.
(ASEBIR criteria
次要结局
- Days of stimulation(From stimulation start (Stimulation Day 1) to trigger day, approx. 8-12 days per participant.)
- Total dose of Gonadotropins(From first day of ovarian stimulation to trigger day (8-12 days total).)
- Number COCs(Assessed on day of oocyte retrieval, approx. 34-36 hours after ovulation trigger.)
- Number MII(Assessed on same day as oocyte retrieval, after denudation and classification)
- Fertilization rate(Assessed on Day 1 after ICSI, 16-18 hours post-injection)
- Time of appearance of the 2nd polar body (tPB2)(Recorded via time-lapse system, within first 8 hours post-ICSI (Day 0).)
- Time of pronuclei appearance (tPNa)(Measured on Day 1 post-ICSI using time-lapse monitoring.)
- Evaluation of both pronuclei (PN)(Assessed during pronuclear stage on Day 1 post-ICSI.)
- Time of pronuclei disappearance (tPNf)(Recorded by time-lapse imaging, approx. 20-24 hours post-ICSI.)
- Time of division from 2 to 8 cells(Tracked continuously via time-lapse, from Day 2 to Day 3 post-ICSI)
- Time of compaction (tSC)(Tracked by time-lapse imaging on Day 4 post-ICSI)
- Time of morula (tM)(Recorded by time-lapse on Day 4 post-ICSI.)
- Time of cavitation (tSB)(Recorded by time-lapse on Day 5 post-ICSI.)
- Time of full blastulation (tB)(Measured by time-lapse on Day 5 of embryo culture)
- Total number of day 5 blastocysts(Counted on Day 5 of embryo culture after ICSI)
- Blastocyst formation rate,(Calculated on Day 5 based on 2PN embryos reaching blastocyst stage.)
- Number of embryos cryopreserved(Recorded at time of freezing on Day 5-7 of embryo culture)
- Embryo stage (D5, D6, D7)(Assessed at time of embryo cryopreservation on Day 5 to 7)
- Change in AFC(Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).)
- Change in AMH(Compared between baseline (Visit 2) and end of semaglutide treatment (Visit 5, Week 12).)
- Change in BMI(: Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).)
- Change in WC(: Measured at baseline, Weeks 4, 8, and 12 of semaglutide treatment (Visits 2-5).)