Increase Pregnancy RatePhase 3NCT02916173
Triggering of Follicular Maturation
A Phase 3 study testing Recombinant Human Chorionic Gonadotrophin and human chorionic gonadotrophin + gonadotrophin releasing hormone agonist in people with Increase Pregnancy Rate, run by Assiut University at 1 site in Egypt.
Trial summary
The follicular phase of the menstrual cycle involves the hourly release of gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that regulate follicular growth. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Increase Pregnancy Rate
- What is being tested?
- Recombinant Human Chorionic Gonadotrophin and human chorionic gonadotrophin + gonadotrophin releasing hormone agonist
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Feb 2019
- Phase
- Phase 3
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile couples wishing to do intracytoplasmic injection trial .
- first intracytoplasmic injection trial
- Body mass index:18-30.
- 5-Antral follicular count: more than 5 follicles in one ovary 6-normal, mild or moderate male factor infertility. 7- Antimullerian hormone >1 ng/ml
Who cannot join
- Azoospermic male.
- Body mass index more than 29.
- Patients with endometriosis .
- Antimullerian hormone < 1 ng/ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triggering of Follicular Maturation Using Human Chorionic Gonadotrophin With Gonadotrophin Releasing Hormone Agonist Versus Human Chorionic Gonadotrophin Alone in Antagonist Protocol in Assisted Reproductive Technology : a Randomized Controlled Trial
The follicular phase of the menstrual cycle involves the hourly release of gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant follicle and a small rise in progesterone lead to a gonadotrophic surge. An increase in the amplitude of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte maturity and triggers ovulation approximately
- Conditions
- Increase Pregnancy Rate
- Being tested
- Recombinant Human Chorionic Gonadotrophin, human chorionic gonadotrophin + gonadotrophin releasing hormone agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Chorionic GonadotrophinDrug
Also called Ovitrelle
250 unit intramuscular
human chorionic gonadotrophin + gonadotrophin releasing hormone agonistDrug
250 unit intramuscular + 1 mg subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Human chorionic gonadotrophin group | Experimental | Patients will receive Human chorionic gonadotrohpin injection 5000 unit Receives: Drug: Recombinant Human Chorionic Gonadotrophin |
| Human chorionic gonadotrophin + agonist group | Active comparator | patients will receive both Human chorionic gonadotrophin (2500 unit) and gonadotrophin releasing hormone agonist 1mg leuprolide acetate Receives: Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of M II oocytes in both groups
Measured: 24 hours
Secondary outcomes (2)
Fertilization rate in each group
Measured: 3 days
Clinical pregnancy rate in each group
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increase Pregnancy RateStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916173
- Sponsor's protocol ID
- FM-ART
- Status last verified
- Mar 2019
- First submitted
- 25 Sep 2016
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triggering of Follicular Maturation Using Human Chorionic Gonadotrophin With Gonadotrophin Releasing Hormone Agonist Versus Human Chorionic Gonadotrophin Alone in Antagonist Protocol in Assisted Reproductive Technology : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02916173
- Acronym / sponsor ID
- FM-ART
- Conditions
- Increase Pregnancy Rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 27 Sep 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.
The follicular phase of the menstrual cycle involves the hourly release of gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant follicle and a small rise in progesterone lead to a gonadotrophic surge. An increase in the amplitude of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte maturity and triggers ovulation approximately
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human chorionic gonadotrophin group | Experimental | Drug: Recombinant Human Chorionic GonadotrophinPatients will receive Human chorionic gonadotrohpin injection 5000 unit |
| Human chorionic gonadotrophin + agonist group | Active comparator | Drug: human chorionic gonadotrophin + gonadotrophin releasing hormone agonistpatients will receive both Human chorionic gonadotrophin (2500 unit) and gonadotrophin releasing hormone agonist 1mg leuprolide acetate |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile couples wishing to do intracytoplasmic injection trial .
- first intracytoplasmic injection trial
- Body mass index:18-30.
- 5-Antral follicular count: more than 5 follicles in one ovary 6-normal, mild or moderate male factor infertility. 7- Antimullerian hormone >1 ng/ml
Key exclusion criteria (4 listed)
- Azoospermic male.
- Body mass index more than 29.
- Patients with endometriosis .
- Antimullerian hormone < 1 ng/ml
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 |
|---|---|---|
| Recombinant Human Chorionic GonadotrophinAlso: Ovitrelle250 unit intramuscular | Drug | Human chorionic gonadotrophin group |
| human chorionic gonadotrophin + gonadotrophin releasing hormone agonist250 unit intramuscular + 1 mg subcutaneous | Drug | Human chorionic gonadotrophin + agonist group |
Primary outcome
Number of M II oocytes in both groups
Time frame: 24 hours
2 secondary outcomes
Fertilization rate in each group
Time frame: 3 days
Clinical pregnancy rate in each group
Time frame: 15 days
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 20 Mar 2019.
- Individual participant dataSharing planned: No
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 3 study testing Recombinant Human Chorionic Gonadotrophin and human chorionic gonadotrophin + gonadotrophin releasing hormone agonist in people with Increase Pregnancy Rate, run by Assiut 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 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 20 Mar 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 M II oocytes in both groups (time frame: 24 hours). 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 20 Mar 2019.