Comparison of Vaginal Estradiol and Oral Guaifenesin Interventions in Patients Undergoing Ovulation Induction With Clomiphene Citrate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Clomiphene citrate is commonly used for ovulation induction; however, it may negatively affect endometrial development and cervical mucus quality, which can reduce pregnancy rates. Various adjunctive treatments have been proposed to overcome these antiestrogenic effects.
This randomized clinical trial aimed to compare the effects of vaginal estradiol and oral guaifenesin, alone or in combination, on endometrial thickness, cervical mucus characteristics, and clinical pregnancy rates in women undergoing ovulation induction with clomiphene citrate.
A total of 90 women with infertility undergoing ovulation induction were randomly assigned to one of three treatment groups: clomiphene citrate plus guaifenesin, clomiphene citrate plus vaginal estradiol, or clomiphene citrate combined with both guaife
详细描述
This study was designed as a single-center, randomized, parallel-group interventional clinical trial conducted at a university-affiliated tertiary care hospital. Women diagnosed with infertility and scheduled for ovulation induction with clomiphene citrate were eligible for inclusion.
Participants were randomly assigned to one of three treatment arms: clomiphene citrate plus oral guaifenesin, clomiphene citrate plus vaginal estradiol, or clomiphene citrate combined with both oral guaifenesin and vaginal estradiol. Clomiphene citrate was administered according to standard ovulation induction protocols. Adjunctive treatments were initiated during the follicular phase.
Baseline demographic and clinical characteristics were recorded. Follicular development and endometrial thickness were assessed by transvaginal ultrasonography. Cervical mucus characteristics, including spinnbarkeit and cervical mucus score, were evaluated during the periovulatory period. Ovulation was triggered when appropriate follicular criteria were met.
The primary outcome of the study was the clinical pregnancy rate. Secondary outcomes included endometrial thickness, cervical mucus quality, ovulation response, cycle cancellation, and miscarriage rate. Statistical analyses were performed to compare outcomes between treatment groups.
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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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Women aged 18 to 40 years
- •Diagnosis of infertility
- •Indication for ovulation induction with clomiphene citrate
- •Regular or irregular menstrual cycles suitable for ovulation induction
- •At least one patent fallopian tube
- •Normal uterine cavity on ultrasonography
- •Male partner with normal or mildly abnormal semen parameters
- •Willingness to participate and provide informed consent
排除标准
- •- Known hypersensitivity to clomiphene citrate, guaifenesin, or estradiol
- •Severe male factor infertility
- •Presence of uterine anomalies or intrauterine pathology
- •Endocrine disorders affecting ovulation (e.g., uncontrolled thyroid disease, hyperprolactinemia)
- •Polycystic ovary syndrome requiring alternative stimulation protocols
- •History of recurrent pregnancy loss
- •Use of hormonal treatment within the last 3 months
研究组 & 干预措施
Clomiphene Citrate + Guaifenesin
Participants received clomiphene citrate for ovulation induction combined with oral guaifenesin during the follicular phase.
干预措施: Clomiphene Citrate. (Drug)
Clomiphene Citrate + Guaifenesin
Participants received clomiphene citrate for ovulation induction combined with oral guaifenesin during the follicular phase.
干预措施: Guaifenesin (Drug)
Clomiphene Citrate + Vaginal Estradiol
Participants received clomiphene citrate for ovulation induction combined with vaginal estradiol during the follicular phase.
干预措施: Clomiphene Citrate. (Drug)
Clomiphene Citrate + Vaginal Estradiol
Participants received clomiphene citrate for ovulation induction combined with vaginal estradiol during the follicular phase.
干预措施: Estradiol (E2) (Drug)
Clomiphene Citrate + Guaifenesin + Vaginal Estradiol
Participants received clomiphene citrate combined with both oral guaifenesin and vaginal estradiol during the follicular phase.
干预措施: Clomiphene Citrate. (Drug)
Clomiphene Citrate + Guaifenesin + Vaginal Estradiol
Participants received clomiphene citrate combined with both oral guaifenesin and vaginal estradiol during the follicular phase.
干预措施: Guaifenesin (Drug)
Clomiphene Citrate + Guaifenesin + Vaginal Estradiol
Participants received clomiphene citrate combined with both oral guaifenesin and vaginal estradiol during the follicular phase.
干预措施: Estradiol (E2) (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: From ovulation trigger administration to confirmation of clinical pregnancy by transvaginal ultrasonography within the same treatment cycle (approximately 4-6 weeks).
Clinical pregnancy was defined as the presence of an intrauterine gestational sac detected by transvaginal ultrasonography.
次要结局
- Endometrial thickness(On the day of ovulation trigger administration (cycle day-specific).)
- Cervical mucus score(During the peri-ovulatory period, from the day before ovulation trigger to the day after ovulation trigger (approximately 2-3 days).)
- Spinnbarkeit(During the peri-ovulatory period, from the day before ovulation trigger to the day after ovulation trigger (approximately 2-3 days).)
- Miscarriage rate(Up to 12 weeks of gestation)
- Cycle cancellation rate(By the end of the treatment cycle (one cycle, approximately 28 days).)
研究者
Gamze Karababa
Medical Doctor
Yuzuncu Yil University