Female InfertilityCC-OVINCT07398924
Vaginal Estradiol and Oral Guaifenesin in Clomiphene Ovulation Induction
A study testing Clomiphene Citrate., Guaifenesin and Estradiol (E2) in people with Female Infertility and Anovulatory Infertility, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Female Infertility, Anovulatory Infertility, Unexplained Infertility
- What is being tested?
- Clomiphene Citrate., Guaifenesin and Estradiol (E2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2022to 23 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Dursun Odabasi Medical Center
Van, Di̇yarbakir, 21640
About this study
Official title: Comparison of Vaginal Estradiol and Oral Guaifenesin Interventions in Patients Undergoing Ovulation Induction With Clomiphene Citrate
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
Read the detailed description
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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- Being tested
- Clomiphene Citrate., Guaifenesin, Estradiol (E2)
- Keywords
- Clomiphene citrate, Ovulation induction, Vaginal estradiol, Guaifenesin, Endometrial thickness, Cervical mucus, Infertility treatment
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene Citrate.Drug
Also called Clomifene Citrate
Clomiphene citrate administered orally for ovulation induction according to standard clinical protocols.
GuaifenesinDrug
Also called Glyceryl guaiacolate
Oral guaifenesin administered during the follicular phase to improve cervical mucus characteristics.
Estradiol (E2)Drug
Also called Vaginal Estradiol
Vaginal estradiol administered during the follicular phase to improve endometrial development.
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene Citrate + Guaifenesin | Experimental | Participants received clomiphene citrate for ovulation induction combined with oral guaifenesin during the follicular phase. Receives: Drug: Clomiphene Citrate.; Drug: Guaifenesin |
| Clomiphene Citrate + Vaginal Estradiol | Experimental | Participants received clomiphene citrate for ovulation induction combined with vaginal estradiol during the follicular phase. Receives: Drug: Clomiphene Citrate.; Drug: Estradiol (E2) |
| Clomiphene Citrate + Guaifenesin + Vaginal Estradiol | Experimental | Participants received clomiphene citrate combined with both oral guaifenesin and vaginal estradiol during the follicular phase. Receives: Drug: Clomiphene Citrate.; Drug: Guaifenesin; Drug: Estradiol (E2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy was defined as the presence of an intrauterine gestational sac detected by transvaginal ultrasonography.
Measured: From ovulation trigger administration to confirmation of clinical pregnancy by transvaginal ultrasonography within the same treatment cycle (approximately 4-6 weeks).
Secondary outcomes (5)
Endometrial thickness
Endometrial thickness was measured by transvaginal ultrasonography.
Measured: On the day of ovulation trigger administration (cycle day-specific).
Cervical mucus score
Cervical mucus quality was evaluated using cervical mucus scoring.
Measured: 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.
Measured: 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.
Measured: Up to 12 weeks of gestation
Cycle cancellation rate
Cycle cancellation was recorded when ovulation induction could not be completed.
Measured: By the end of the treatment cycle (one cycle, approximately 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start6 Jan 2022
- Primary completion6 Jun 2023
- Study completion23 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized into three parallel treatment arms and followed prospectively for outcome assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Karababa, Yuzuncu Yil University
- Investigators
- Gamze K Karababa, Study director, VAN YUZUNCU YİL UNİVERCITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398924
- Sponsor's protocol ID
- YYU-CC-OVI-2022
- Other IDs
- YYU-ETH-2021
- Acronym
- CC-OVI
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal Estradiol and Oral Guaifenesin Interventions in Patients Undergoing Ovulation Induction With Clomiphene Citrate
- ClinicalTrials.gov ID
- NCT07398924
- Acronym / sponsor ID
- CC-OVI / YYU-CC-OVI-2022
- Keywords
- Clomiphene citrate, Ovulation induction, Vaginal estradiol, Guaifenesin, Endometrial thickness, Cervical mucus, Infertility treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomized into three parallel treatment arms and followed prospectively for outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| Clomiphene Citrate + Guaifenesin | Experimental | Drug: Clomiphene Citrate., Drug: GuaifenesinParticipants received clomiphene citrate for ovulation induction combined with oral guaifenesin during the follicular phase. |
| Clomiphene Citrate + Vaginal Estradiol | Experimental | Drug: Clomiphene Citrate., Drug: Estradiol (E2)Participants received clomiphene citrate for ovulation induction combined with vaginal estradiol during the follicular phase. |
| Clomiphene Citrate + Guaifenesin + Vaginal Estradiol | Experimental | Drug: Clomiphene Citrate., Drug: Guaifenesin, Drug: Estradiol (E2)Participants received clomiphene citrate combined with both oral guaifenesin and vaginal estradiol during the follicular phase. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- - 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomiphene Citrate.Also: Clomifene CitrateClomiphene citrate administered orally for ovulation induction according to standard clinical protocols. | Drug | Clomiphene Citrate + Guaifenesin, Clomiphene Citrate + Guaifenesin + Vaginal Estradiol, Clomiphene Citrate + Vaginal Estradiol |
| GuaifenesinAlso: Glyceryl guaiacolateOral guaifenesin administered during the follicular phase to improve cervical mucus characteristics. | Drug | Clomiphene Citrate + Guaifenesin, Clomiphene Citrate + Guaifenesin + Vaginal Estradiol |
| Estradiol (E2)Also: Vaginal EstradiolVaginal estradiol administered during the follicular phase to improve endometrial development. | Drug | Clomiphene Citrate + Guaifenesin + Vaginal Estradiol, Clomiphene Citrate + Vaginal Estradiol |
Primary outcome
Clinical pregnancy rate
Time frame: 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.
5 secondary outcomes
Endometrial thickness
Time frame: On the day of ovulation trigger administration (cycle day-specific).
Cervical mucus score
Time frame: During the peri-ovulatory period, from the day before ovulation trigger to the day after ovulation trigger (approximately 2-3 days).
Spinnbarkeit
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
Time frame: Up to 12 weeks of gestation
Cycle cancellation rate
Time frame: By the end of the treatment cycle (one cycle, approximately 28 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamze K Karababa study director
VAN YUZUNCU YİL UNİVERCITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clomiphene Citrate., Guaifenesin and Estradiol (E2) in people with Female Infertility and Anovulatory Infertility, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: From ovulation trigger administration to confirmation of clinical pregnancy by transvaginal ultrasonography within the same treatment cycle (approximately 4-6 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.