PCOSNCT03527979
Effect of Laparoscopic Ovarian Drilling on Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
A study testing IVF/ICSI in people with PCOS, run by Ain Shams University at 1 site in Egypt.
Trial summary
the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- IVF/ICSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to Sep 2018
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 25 and 35
- patients with established PCOS
- history at least one year infertility
- no response to clomiphene citrate for at least three cycles
Who cannot join
- history of previous IVF/ICSI
- chronic disease such as thyroid disorder and DM
- infertility due to sever male factor
- sever endometriosis
- infertility due to uterine factor such as multiple fibroid
- body mass index > 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laparoscopic Ovarian Drilling on the Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. this study is undertaken to evaluate the in vitro fertilisation outcomes in clomiphene-resistant women with PCOS who were treated with LOD.
- Conditions
- PCOS
- Being tested
- IVF/ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF/ICSIProcedure or surgery
IVF/ICSI
| Study group | Role | What they receive |
|---|---|---|
| PCOS women with history of LOD before IVF/ICSI | Active comparator | Not described Receives: Procedure: IVF/ICSI |
| PCOS women without history of drilling | Active comparator | Not described Receives: Procedure: IVF/ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound
Pregnancy confirmed by b-hcg and visualization of gestational sac by ultrasound
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Mar 2018
- Primary completionAug 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab adel kamal, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527979
- Sponsor's protocol ID
- rkamal
- Status last verified
- May 2018
- First submitted
- 19 Apr 2018
- Last updated
- 17 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Ovarian Drilling on the Outcomes of in Vitro Fertilisation in Clomiphene-resistant Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03527979
- Acronym / sponsor ID
- rkamal
- Conditions
- PCOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 17 May 2018 (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.
the polycystic ovarian syndrome is associated with an ovulation and infertility. recently the laparoscopic ovarian drilling has been used as surgical treatment for ovulation in women with polycystic ovarian syndrome, although its mechanism and outcomes are still unclear. this study is undertaken to evaluate the in vitro fertilisation outcomes in clomiphene-resistant women with PCOS who were treated with LOD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS women with history of LOD before IVF/ICSI | Active comparator | Procedure: IVF/ICSI |
| PCOS women without history of drilling | Active comparator | Procedure: IVF/ICSI |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 25 and 35
- patients with established PCOS
- history at least one year infertility
- no response to clomiphene citrate for at least three cycles
Key exclusion criteria (6 listed)
- history of previous IVF/ICSI
- chronic disease such as thyroid disorder and DM
- infertility due to sever male factor
- sever endometriosis
- infertility due to uterine factor such as multiple fibroid
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 |
|---|---|---|
| IVF/ICSIIVF/ICSI | Procedure or surgery | PCOS women with history of LOD before IVF/ICSI, PCOS women without history of drilling |
Primary outcome
clinical pregnancy rate confirmed by b-hcg and visualizations of gestational sac by ultrasound
Time frame: 3 months
Pregnancy confirmed by b-hcg and visualization of gestational sac by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
Related trials for PCOS
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVF/ICSI in people with PCOS, run by Ain Shams University 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 4 inclusion and 6 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 17 May 2018. 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?
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 confirmed by b-hcg and visualizations of gestational sac by ultrasound (time frame: 3 months). 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 17 May 2018.