InfertilityPhase 2NCT02335736
Antagonist Protocol in IVF
A Phase 2 study testing Gonadotropins releasing hormone antagonist in people with Infertility, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients? Read more about this study
- Who is it for?
- Ages 20 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Gonadotropins releasing hormone antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Apr 2016
- Phase
- Phase 2
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 20- 44 years
- Poor responder females according to Bologna criteria
- Polycystic ovarian disease females according to Rotterdam criteria
- Females with infertility causes other than poor responders, or PCO; male factor or tubal block
Who cannot join
- refusal to get enrolled in the study
- cases of infertility due to severe male factor
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr el aini hospital
Cairo, Cairo Governorate
Dina M Dakhly, MD, 01003498919 ext. 002, Dinadakhly@gmail.com
Dina M Dakhly, MD
About this study
Official title: Can Antagonist Protocol be the Protocol of Choice in in Vitro Fertilization Patients?
The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients?
- Conditions
- Infertility
- Being tested
- Gonadotropins releasing hormone antagonist
- Keywords
- infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropins releasing hormone antagonistDrug
Also called Cetrotide, Serono, Geneva, Switzerland
| Study group | Role | What they receive |
|---|---|---|
| Normal | Active comparator | Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Receives: Drug: Gonadotropins releasing hormone antagonist |
| Poor responders | Active comparator | Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC Receives: Drug: Gonadotropins releasing hormone antagonist |
| Polycystic ovarian disease | Active comparator | Human menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant(Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC Receives: Drug: Gonadotropins releasing hormone antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes collected and fertilized
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionApr 2016 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina M Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335736
- Sponsor's protocol ID
- AA2015
- Status last verified
- Feb 2016
- First submitted
- 7 Jan 2015
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Antagonist Protocol be the Protocol of Choice in in Vitro Fertilization Patients?
- ClinicalTrials.gov ID
- NCT02335736
- Acronym / sponsor ID
- AA2015
- Conditions
- Infertility
- Keywords
- infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 12 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 antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal | Active comparator | Drug: Gonadotropins releasing hormone antagonistHuman menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. |
| Poor responders | Active comparator | Drug: Gonadotropins releasing hormone antagonistHuman menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC |
| Polycystic ovarian disease | Active comparator | Drug: Gonadotropins releasing hormone antagonistHuman menopausal gonadotrophin IM daily was administrated from day 2 of the cycle. The Gonadotropins releasing hormone antagonist GnRH ant(Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age: 20- 44 years
- Poor responder females according to Bologna criteria
- Polycystic ovarian disease females according to Rotterdam criteria
- Females with infertility causes other than poor responders, or PCO; male factor or tubal block
Key exclusion criteria (2 listed)
- refusal to get enrolled in the study
- cases of infertility due to severe male factor
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 |
|---|---|---|
| Gonadotropins releasing hormone antagonistAlso: Cetrotide, Serono, Geneva, Switzerland | Drug | Normal, Polycystic ovarian disease, Poor responders |
Primary outcome
number of oocytes collected and fertilized
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
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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.
Dina M Dakhly, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gonadotropins releasing hormone antagonist in people with Infertility, run by Woman's Health University Hospital, Egypt 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 2 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 15 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dina M Dakhly, MD (01003498919 ext. 002, dinadakhly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of oocytes collected and fertilized (time frame: 6 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 15 Feb 2016.