Infertility Indicated for ICSIPhase 4AIPRICSINCT02741154
Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI
A Phase 4 study testing induction with aromataze inhibitor, HMG and GnRh a in people with Infertility Indicated for ICSI, run by Minia University at 1 site in Egypt.
Trial summary
study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Infertility Indicated for ICSI
- What is being tested?
- induction with aromataze inhibitor, HMG and GnRh a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2016to 3 Sep 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertlity indicated for ICSI
- Ovarian factor
- Tubal factor
- Unexplained infertility
- poor responders
Who cannot join
- Expected high responder
- Endometriosis
- Male and uterine factors
- Ovarian mass or cyst
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI(Intracytoplasmic Sperm Injection) a Case Control Study
study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI
Read the detailed description
This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled .
Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol
- Conditions
- Infertility Indicated for ICSI
- Being tested
- induction with aromataze inhibitor, HMG, GnRh a, HCG
- Keywords
- aromataze inhibitor, poor responder ,induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction with aromataze inhibitorDrug
Also called letrozole
letrozole 2.5mg once daily start in the first day of menses for 5days
HMGDrug
Also called merional
HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter
GnRh aDrug
Also called decapeptyl
antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection
HCGDrug
Also called choriomon
10.000 IU HCG injection when at least three follicles reach 17mm in diameter
| Study group | Role | What they receive |
|---|---|---|
| aromataze group | Experimental | patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection Receives: Drug: induction with aromataze inhibitor; Drug: HMG; Drug: GnRh a; Drug: HCG |
| classic group | Active comparator | same protocol for induction without aromataze inhibitor Receives: Drug: HMG; Drug: GnRh a; Drug: HCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)
measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report
Measured: day of HCG injection
quality of ova
After ova picking up examination of all ova under microscope and report how many ova reach metaphase II (quality) if more than 3 ova reach metaphase II considered satisfactory quality of ova in the current cycle
Measured: day of ovum pick up
Secondary outcomes (1)
pregnancy rate
presence of clinical pregnancy
Measured: 14 days after ovum pick up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start12 Aug 2016
- Primary completion24 Aug 2017
- Study completion3 Sep 2017
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 Infertility Indicated for ICSIStudies of the same condition, open and under way.
- More trials run by Minia 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Elkhateeb, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741154
- Sponsor's protocol ID
- MUH 20167
- Other IDs
- MUH20167
- Acronym
- AIPRICSI
- Status last verified
- Sep 2017
- First submitted
- 12 Apr 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Mitwally MF, Casper RF. Aromatase inhibition improves ovarian response to follicle-stimulating hormone in poor responders. Fertil Steril. 2002 Apr;77(4):776-80. doi: 10.1016/s0015-0282(01)03280-0.
PubMed 11937133
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI(Intracytoplasmic Sperm Injection) a Case Control Study
- ClinicalTrials.gov ID
- NCT02741154
- Acronym / sponsor ID
- AIPRICSI / MUH 20167
- Conditions
- Infertility Indicated for ICSI
- Keywords
- aromataze inhibitor, poor responder ,induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 12 Aug 2016
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 3 Sep 2017 (actual)
- First posted
- 18 Apr 2016 (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.
study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI
Detailed description
This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled .
Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aromataze group | Experimental | Drug: induction with aromataze inhibitor, Drug: HMG, Drug: GnRh a, Drug: HCGpatients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection |
| classic group | Active comparator | Drug: HMG, Drug: GnRh a, Drug: HCGsame protocol for induction without aromataze inhibitor |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- infertlity indicated for ICSI
- Ovarian factor
- Tubal factor
- Unexplained infertility
- poor responders
Key exclusion criteria (4 listed)
- Expected high responder
- Endometriosis
- Male and uterine factors
- Ovarian mass or cyst
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 |
|---|---|---|
| induction with aromataze inhibitorAlso: letrozoleletrozole 2.5mg once daily start in the first day of menses for 5days | Drug | aromataze group |
| HMGAlso: merionalHMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter | Drug | aromataze group, classic group |
| GnRh aAlso: decapeptylantagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection | Drug | aromataze group, classic group |
| HCGAlso: choriomon10.000 IU HCG injection when at least three follicles reach 17mm in diameter | Drug | aromataze group, classic group |
Primary outcome
Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)
Time frame: day of HCG injection
measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report
quality of ova
Time frame: day of ovum pick up
After ova picking up examination of all ova under microscope and report how many ova reach metaphase II (quality) if more than 3 ova reach metaphase II considered satisfactory quality of ova in the current cycle
1 secondary outcome
pregnancy rate
Time frame: 14 days after ovum pick up
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 6 Sep 2017.
- Results publication: PubMed 11937133Mitwally MF, Casper RF. Aromatase inhibition improves ovarian response to follicle-stimulating hormone in poor responders. Fertil Steril. 2002 Apr;77(4):776-80. doi: 10.1016/s0015-0282(01)03280-0.
- Individual participant dataSharing planned: Undecided
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 Phase 4 study testing induction with aromataze inhibitor, HMG and GnRh a in people with Infertility Indicated for ICSI, run by Minia 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 5 inclusion and 4 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 6 Sep 2017. 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.
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 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?
Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova) (time frame: day of HCG injection). The study lists 2 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 NCT02741154, 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 Sep 2017.