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| ID | Type | Description | Link |
|---|---|---|---|
| YYU-ETH-2021 | Other Identifier | Yuzuncu Yil University Ethics Committee Approval |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene Citrate + Guaifenesin | Experimental | Participants received clomiphene citrate for ovulation induction combined with oral guaifenesin during the follicular phase. |
|
| Clomiphene Citrate + Vaginal Estradiol | Experimental | Participants received clomiphene citrate for ovulation induction combined with vaginal estradiol during the follicular phase. |
|
| Clomiphene Citrate + Guaifenesin + Vaginal Estradiol | Experimental | Participants received clomiphene citrate combined with both oral guaifenesin and vaginal estradiol during the follicular phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomiphene Citrate. | Drug | Clomiphene citrate administered orally for ovulation induction according to standard clinical protocols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Clinical pregnancy was defined as the presence of an intrauterine gestational sac detected by transvaginal ultrasonography. | From ovulation trigger administration to confirmation of clinical pregnancy by transvaginal ultrasonography within the same treatment cycle (approximately 4-6 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness | Endometrial thickness was measured by transvaginal ultrasonography. | On the day of ovulation trigger administration (cycle day-specific). |
| Cervical mucus score | Cervical mucus quality was evaluated using cervical mucus scoring. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gamze K Karababa | VAN YUZUNCU YÄ°L UNÄ°VERCITY | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Van Yuzuncu Yil University Dursun Odabasi Medical Center | Van | Di̇yarbakir | 21640 | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Related Info | View source |
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Individual participant data will not be shared due to ethical and privacy considerations.
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D006140 | Guaifenesin |
| D000111 | Acetylcysteine |
| D004958 | Estradiol |
| C000654104 | segesterone acetate and ethinyl estradiol vaginal system |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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Participants were randomized into three parallel treatment arms and followed prospectively for outcome assessment.
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Outcome assessors were blinded to treatment allocation.
|
| Guaifenesin | Drug | Oral guaifenesin administered during the follicular phase to improve cervical mucus characteristics. |
|
|
| Estradiol (E2) | Drug | Vaginal estradiol administered during the follicular phase to improve endometrial development. |
|
|
| 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. | 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. | Up to 12 weeks of gestation |
| Cycle cancellation rate | Cycle cancellation was recorded when ovulation induction could not be completed. | By the end of the treatment cycle (one cycle, approximately 28 days). |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D010647 | Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |