AnovulationNCT02269306
Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
A study testing clomiphen citrate in people with Anovulation, run by Menoufia Obstetrics and Gynecology Group at 1 site in Egypt.
Trial summary
The purpose of this study is to determine whether Visceral fat area and other criteria assessed during initial screening could predict the response to ovulation induction with clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anovulation
- What is being tested?
- clomiphen citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2011to Jan 2013
- 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
- The study included 150 infertile women(age from 18 to 40 years) with PCOS diagnosed by the presence of at least two of the following [15]:
- Clinical hyperandrogenism: Hirsutism or acne vulgaris and/or biochemical hyperandrogenism (total testosterone >88 ng/dl or DHEAS >275 ug/dL)[16]. (2) Menstrual and/or ovulatory disturbances, mainly oligomenorrhea (interval between vaginal bleeding >35 days and < 6 months) or amenorrhea (bleeding interval >6 months). (3) Polycystic ovaries as visualized by transvaginal ultrasound (either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume >10 cm3).
Who cannot join
- Patients having one or more of these criteria were excluded; Age <18 years or >40 years, body mass index (BMI) <18.5 kg/m2 or >35 kg/m2, pregnancy, endocrine disorders, systemic disease, current or previous (within the last 3 months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction or dopaminergic agents, use of antidiabetes, antiobesity drugs or history of tubal or ovarian surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visceral Fat Area and Other Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
The purpose of this study is to determine whether Visceral fat area and other criteria assessed during initial screening could predict the response to ovulation induction with clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).
Read the detailed description
The study was carried out on 150 patients with PCOS. Initial CC doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.Statistical methods Distribution of characteristics in patients is presented as the mean ± SD. We used the Mann-Whitney U test for exploratory comparison of initial parameters between responders and nonresponders. The univariate and multivariate relation with response to CC was assessed using logistic regression analysis. Backward stepwise elimination was used for the multivariate logistic analysis of prediction of patients being CRA, and P < 0.10 was used as a cut-off level for elimination of non-significant predictors from the prognostic model. The area under the receiver operating characteristics (ROC) curve (AUC) was used to assess the discriminative ability of the logistic models. SPSS with statistical package version 17 (SPSS Inc., Chicago, IL) and MedCalc Software version 12.4, (Ostend, Belgium) were employed for data analysis.
- Conditions
- Anovulation
- Being tested
- clomiphen citrate
- Keywords
- PCOS, clomiphene citrate, AMH, visceral fat area, HOMA-IR
- Medical subject headings
- Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clomiphen citrateDrug
Also called clomid
The study was carried out on 150 patients with PCOS. Initial clomiphen citrate (CC) doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.
| Study group | Role | What they receive |
|---|---|---|
| clomiphen citrate(cc) | Experimental | Initial CC doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. Receives: Drug: clomiphen citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovulation
Measured: 3 months ( cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnovulationStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia Obstetrics and Gynecology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hamed Ellakwa, Menoufia Obstetrics and Gynecology Group
- Investigators
- Hamed El Ellakwa, MD, Principal investigator, Menoufiya faculty of medicine,menoufiya university,ministry of higher education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269306
- Sponsor's protocol ID
- Menoufia OGG-1
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellakwa HE, Sanad ZF, Hamza HA, Emara MA, Elsayed MA. Predictors of patient responses to ovulation induction with clomiphene citrate in patients with polycystic ovary syndrome experiencing infertility. Int J Gynaecol Obstet. 2016 Apr;133(1):59-63. doi: 10.1016/j.ijgo.2015.09.008. Epub 2015 Dec 17.
PubMed 26848057
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Fat Area and Other Predictors of Ovarian Response During Clomiphene Citrate Ovulation Induction in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02269306
- Acronym / sponsor ID
- Menoufia OGG-1
- Conditions
- Anovulation
- Keywords
- PCOS, clomiphene citrate, AMH, visceral fat area, HOMA-IR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Menoufia Obstetrics and Gynecology GroupUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Oct 2014 (estimated)
- 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.
The purpose of this study is to determine whether Visceral fat area and other criteria assessed during initial screening could predict the response to ovulation induction with clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS).
Detailed description
The study was carried out on 150 patients with PCOS. Initial CC doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.Statistical methods Distribution of characteristics in patients is presented as the mean ± SD. We used the Mann-Whitney U test for exploratory comparison of initial parameters between responders and nonresponders. The univariate and multivariate relation with response to CC was assessed using logistic regression analysis. Backward stepwise elimination was used for the multivariate logistic analysis of prediction of patients being CRA, and P < 0.10 was used as a cut-off level for elimination of non-significant predictors from the prognostic model. The area under the receiver operating characteristics (ROC) curve (AUC) was used to assess the discriminative ability of the logistic models. SPSS with statistical package version 17 (SPSS Inc., Chicago, IL) and MedCalc Software version 12.4, (Ostend, Belgium) were employed for data analysis.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clomiphen citrate(cc) | Experimental | Drug: clomiphen citrateInitial CC doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The study included 150 infertile women(age from 18 to 40 years) with PCOS diagnosed by the presence of at least two of the following [15]:
Key exclusion criteria (1 listed)
- Patients having one or more of these criteria were excluded; Age <18 years or >40 years, body mass index (BMI) <18.5 kg/m2 or >35 kg/m2, pregnancy, endocrine disorders, systemic disease, current or previous (within the last 3 months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction or dopaminergic agents, use of antidiabetes, antiobesity drugs or history of tubal or ovarian surgery.
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 |
|---|---|---|
| clomiphen citrateAlso: clomidThe study was carried out on 150 patients with PCOS. Initial clomiphen citrate (CC) doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point. | Drug | clomiphen citrate(cc) |
Primary outcome
ovulation
Time frame: 3 months ( cycles)
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 21 Oct 2014.
- Derived from this study: PubMed 26848057Ellakwa HE, Sanad ZF, Hamza HA, Emara MA, Elsayed MA. Predictors of patient responses to ovulation induction with clomiphene citrate in patients with polycystic ovary syndrome experiencing infertility. Int J Gynaecol Obstet. 2016 Apr;133(1):59-63. doi: 10.1016/j.ijgo.2015.09.008. Epub 2015 Dec 17.
Related trials for Anovulation
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingObservational study
Half-dose vs Conventional-dose Cetrorelix in ICSI Cycles
Infertility, Infertility, Female
Recruiting
Sperm Preparation Prior to Intrauterine Insemination Study
Infertility, Infertility Secondary
Not yet recruiting
Ovarian Stromal Stiffness and Ovarian Reserve Parameters Via Transvaginal Shear Wave Elastography
Ovarian Reserve Markers, Ovarian Function
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.
Hamed El Ellakwa, MD principal investigator
Menoufiya faculty of medicine,menoufiya university,ministry of higher education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clomiphen citrate in people with Anovulation, run by Menoufia Obstetrics and Gynecology Group at 1 site in Egypt.
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 2 inclusion and 1 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 21 Oct 2014. 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 Egypt. 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?
ovulation (time frame: 3 months ( cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02269306, which also lists 1 linked publication.
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 21 Oct 2014.