InfertilityPhase 4NCT02456792
IVF Versus LOD in Women With CC Resistant PCOS
A Phase 4 study testing IVF and LOD in people with Infertility and Polycystic Ovarian Syndrome, run by Mohamed Sayed Abdelhafez at 2 sites in Egypt.
Trial summary
The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovarian Syndrome
- What is being tested?
- IVF and LOD
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2016to May 2017
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Who cannot join
- Age < 20 or > 35 years.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
- Metabolic or hormonal abnormalities.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Fertility Care Unit (FCU) in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
Private fertility care centers
Al Mansurah, Dakahlia Governorate
About this study
Official title: In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).
Read the detailed description
Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Being tested
- IVF, LOD
- Keywords
- PCOS, Clomiphene citrate resistant, LOD, IVF
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVFProcedure or surgery
Also called Intracytoplasmic sperm injection (ICSI)
Women will undergo one IVF cycle
LODProcedure or surgery
Also called Laparoscopic ovarian diathermy
Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months
| Study group | Role | What they receive |
|---|---|---|
| IVF group | Active comparator | Women will undergo one full IVF cycle Receives: Procedure: IVF |
| LOD group | Active comparator | Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months Receives: Procedure: LOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Number of live births divided by the number of women
Measured: 9 months
Secondary outcomes (4)
Clinical pregnancy rate
Number of clinical pregnancies divided by the number of women
Measured: 6-8 weeks gestational age
Multifetal pregnancy rate
Number of multifetal pregnancies divided by the number of clinical pregnancies
Measured: 12 weeks gestational age
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Measured: 12 weeks gestational age
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Measured: Within 9 days of final triggering of oocyte maturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Sayed Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Sayed Abdelhafez, Mansoura University
- Investigators
- Ahmed Gibreel, Dr, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, Dr, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456792
- Sponsor's protocol ID
- AG1
- Status last verified
- May 2017
- First submitted
- 23 May 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT02456792
- Acronym / sponsor ID
- AG1
- Conditions
- Infertility, Polycystic Ovarian Syndrome
- Keywords
- PCOS, Clomiphene citrate resistant, LOD, IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mohamed Sayed AbdelhafezUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 29 May 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 purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus laparoscopic ovarian drilling (LOD) in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).
Detailed description
Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF group | Active comparator | Procedure: IVFWomen will undergo one full IVF cycle |
| LOD group | Active comparator | Procedure: LODWomen will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertile women with PCOS as defined by the Rotterdam criteria.
- CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).
Key exclusion criteria (6 listed)
- Age < 20 or > 35 years.
- Presence of any infertility factor other than anovulatory PCOS.
- Previous history of ovarian surgery or surgical removal of one ovary.
- Previous exposure to cytotoxic drugs or pelvic irradiation.
- Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
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 |
|---|---|---|
| IVFAlso: Intracytoplasmic sperm injection (ICSI)Women will undergo one IVF cycle | Procedure or surgery | IVF group |
| LODAlso: Laparoscopic ovarian diathermyWomen will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months | Procedure or surgery | LOD group |
Primary outcome
Live birth rate
Time frame: 9 months
Number of live births divided by the number of women
4 secondary outcomes
Clinical pregnancy rate
Time frame: 6-8 weeks gestational age
Multifetal pregnancy rate
Time frame: 12 weeks gestational age
Miscarriage rate
Time frame: 12 weeks gestational age
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Time frame: Within 9 days of final triggering of oocyte maturation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Gibreel, Dr principal investigator
Mansoura University
Mohamed S Abdelhafez, Dr study director
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IVF and LOD in people with Infertility and Polycystic Ovarian Syndrome, run by Mohamed Sayed Abdelhafez at 2 sites 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 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: withdrawn, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Live birth rate (time frame: 9 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 10 May 2017.