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
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. ''
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Clomiphene citrate administered orally for ovulation induction according to standard clinical protocols.
Oral guaifenesin administered during the follicular phase to improve cervical mucus characteristics.
Vaginal estradiol administered during the follicular phase to improve endometrial development.
Van Yuzuncu Yil University Dursun Odabasi Medical Center
Van, Di̇yarbakir, Turkey (Türkiye)
Clinical pregnancy rate
Clinical pregnancy was defined as the presence of an intrauterine gestational sac detected by transvaginal ultrasonography.
Time frame: From ovulation trigger administration to confirmation of clinical pregnancy by transvaginal ultrasonography within the same treatment cycle (approximately 4-6 weeks).
Endometrial thickness
Endometrial thickness was measured by transvaginal ultrasonography.
Time frame: On the day of ovulation trigger administration (cycle day-specific).
Cervical mucus score
Cervical mucus quality was evaluated using cervical mucus scoring.
Time frame: During the peri-ovulatory period, from the day before ovulation trigger to the day after ovulation trigger (approximately 2-3 days).
Spinnbarkeit
Spinnbarkeit was assessed as an indicator of cervical mucus stretchability.
Time frame: During the peri-ovulatory period, from the day before ovulation trigger to the day after ovulation trigger (approximately 2-3 days).
Miscarriage rate
Miscarriage was defined as pregnancy loss before 12 weeks of gestation.
Time frame: Up to 12 weeks of gestation
Cycle cancellation rate
Cycle cancellation was recorded when ovulation induction could not be completed.
Time frame: By the end of the treatment cycle (one cycle, approximately 28 days).
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