Asymptomatic DiseasesNCT02345837
Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles
A study testing endometrial sampling and clomiphene citrate in people with Asymptomatic Diseases, run by Al Hayat National Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Diseases
- What is being tested?
- endometrial sampling and clomiphene citrate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2014to Sep 2016
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male partner should have a normal semen count and motility according to world health organization criteria (Murray et al., 2012).
- Primary, secondary or unexplained infertility for at least one year.
- Failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles.
- Age varies from 20-35 years with at least one year of infertility.
- Body mass index between 19-30 kg/m2.
- Day 2 serum FSH< 12 IU/ml.
Show all 9Show fewer
- Normal uterine cavity on hystrosalpingography.
- At least one patent tube of normal appearance on HSG.
- No previous attempts of intrauterine insemination (IUI) or in vitro fertilization (IVF).
Who cannot join
- Infertility due to tubal factor or male factor.
- Intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope.
- Hypogonadotrophic hypogonadism.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University
Shebin Elkom
mohamed maher, +966558198655, mohamaher2015@gmail.com
About this study
The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.
Read the detailed description
Patients will be randomized using a list of computer generated random sample into two groups:
Group 1: Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.
Group 2: Couples who will undergo ovulation induction with clomiphene citrate. The drug chosen for ovulation induction in both groups will be clomephine citrate.
Timing and technique of endometrial sampling:
Timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. Technique: this will be done using the pipelle method (Williams et al., 2008).
The procedure is as follows:
- Vaginal speculum to expose the uterine cervix then sterilization by saline.
- The piston positioned at the extreme distal end of the sheath then the Pipelle is inserted gently through the cervical canal into the cavity of the uterus.
- While holding the sheath in position with one hand, the other hand rapidly pulls the piston firmly and without interruption.
- A negative pressure within the sheath will draw the tissue into the curette opening at the distal end of the sheath and captures the separated tissue within its lumen.
- Conditions
- Asymptomatic Diseases
- Being tested
- endometrial sampling, clomiphene citrate
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial samplingDevice
injury to the endometrium
clomiphene citrateDrug
Also called clomid
ovulation induction by 100mg clomiphene citrate
| Study group | Role | What they receive |
|---|---|---|
| clomiphene and endometrial sampling | Active comparator | Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate. Receives: Device: endometrial sampling; Drug: clomiphene citrate |
| clomiphene citrate | Active comparator | Couples who will undergo ovulation induction with clomiphene citrate. Receives: Drug: clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate.
Measured: one year
Miscarriage rate.
Measured: one year
Multiple pregnancy rates
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startFeb 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
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 Asymptomatic DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Hayat National Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Principal investigator, mohamed maher, Al Hayat National Hospital
- Investigators
- menoufia university, Study chair, menoufia fuculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345837
- Sponsor's protocol ID
- menoufia ob/gyn
- Status last verified
- Apr 2016
- First submitted
- 20 Jan 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Helmy MEE, Maher MA, Elkhouly NI, Ramzy M. A randomized trial of local endometrial injury during ovulation induction cycles. Int J Gynaecol Obstet. 2017 Jul;138(1):47-52. doi: 10.1002/ijgo.12178. Epub 2017 May 4.
PubMed 28397981
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles
- ClinicalTrials.gov ID
- NCT02345837
- Acronym / sponsor ID
- menoufia ob/gyn
- Conditions
- Asymptomatic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Al Hayat National HospitalUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 26 Jan 2015 (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 aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.
Detailed description
Patients will be randomized using a list of computer generated random sample into two groups:
Group 1: Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.
Group 2: Couples who will undergo ovulation induction with clomiphene citrate. The drug chosen for ovulation induction in both groups will be clomephine citrate.
Timing and technique of endometrial sampling:
Timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. Technique: this will be done using the pipelle method (Williams et al., 2008).
The procedure is as follows:
- Vaginal speculum to expose the uterine cervix then sterilization by saline.
- The piston positioned at the extreme distal end of the sheath then the Pipelle is inserted gently through the cervical canal into the cavity of the uterus.
- While holding the sheath in position with one hand, the other hand rapidly pulls the piston firmly and without interruption.
- A negative pressure within the sheath will draw the tissue into the curette opening at the distal end of the sheath and captures the separated tissue within its lumen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clomiphene and endometrial sampling | Active comparator | Device: endometrial sampling, Drug: clomiphene citrateCouples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate. |
| clomiphene citrate | Active comparator | Drug: clomiphene citrateCouples who will undergo ovulation induction with clomiphene citrate. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male partner should have a normal semen count and motility according to world health organization criteria (Murray et al., 2012).
- Primary, secondary or unexplained infertility for at least one year.
- Failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles.
- Age varies from 20-35 years with at least one year of infertility.
- Body mass index between 19-30 kg/m2.
Key exclusion criteria (3 listed)
- Infertility due to tubal factor or male factor.
- Intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope.
- Hypogonadotrophic hypogonadism.
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 |
|---|---|---|
| endometrial samplinginjury to the endometrium | Device | clomiphene and endometrial sampling |
| clomiphene citrateAlso: clomidovulation induction by 100mg clomiphene citrate | Drug | clomiphene and endometrial sampling, clomiphene citrate |
Primary outcome
Clinical pregnancy rate.
Time frame: one year
Miscarriage rate.
Time frame: one year
Multiple pregnancy rates
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 28397981Helmy MEE, Maher MA, Elkhouly NI, Ramzy M. A randomized trial of local endometrial injury during ovulation induction cycles. Int J Gynaecol Obstet. 2017 Jul;138(1):47-52. doi: 10.1002/ijgo.12178. Epub 2017 May 4.
Related trials for Asymptomatic Diseases
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Recruiting
Assessment of a Portable Digital Device for Quantified Analysis of Markerless Walking in Volunteers With Neuromuscular Diseases or Asymptomatic Volunteers
Spinal Muscular Atrophy (SMA), Charcot-Marie-Tooth
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
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.
menoufia university study chair
menoufia fuculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial sampling and clomiphene citrate in people with Asymptomatic Diseases, run by Al Hayat National Hospital 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed maher (+966558198655, mohamaher2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate. (time frame: one year). The study lists 3 primary outcomes in all. 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 NCT02345837, 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 6 Apr 2016.