InfertilityNCT04749979
Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin
A study testing Agonist (decapeptyl ) and HCG ( eg. Choriomon ) in people with Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Estradiol valerate in the form of cycloprogenova™ (white tablet only) was started on day 2 or 3 of cycle with oral dose 4 mg divided on 2 doses in addition to Aspocid 75 mg once daily with folic acid 500 mcg once daily. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Agonist (decapeptyl ) and HCG ( eg. Choriomon )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Feb 2021to 1 Jul 2021
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS patients according to Rotterdam criteria
- Female age between 20 and 40 years.
- Primary or secondary infertility.
- Body mass index (BMI) between 18 and 40 kg/m2.
Who cannot join
- Ovarian endometriosis.
- Ovarian cysts before induction.
- Known uncontrolled endocrinal abnormalities (like hypo or hyperthyroidism)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aljazeera( Al Gazeera) hospital
Giza
Mahmoud Alalfy, PhD, +201002611058 ext. +2, mahmoudalalfy@ymail.com
About this study
Official title: Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin in IVF Cycles
Estradiol valerate in the form of cycloprogenova™ (white tablet only) was started on day 2 or 3 of cycle with oral dose 4 mg divided on 2 doses in addition to Aspocid 75 mg once daily with folic acid 500 mcg once daily.
Read the detailed description
U/S was done on day 9 or 10 of cycle to assess endometrial thickness, then every other day until endometrial thickness of 8 mm or more is reached and when endometrial thickness reaches 8 mm or more FET was planned. Progesterone in the form of prontogest™ 400 mg vaginal suppository twice dTwo to Four Day 5 Embryos was transferred
- Conditions
- Infertility
- Being tested
- Agonist (decapeptyl ), HCG ( eg. Choriomon )
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agonist (decapeptyl )Drug
giving agonist
HCG ( eg. Choriomon )Drug
giving HCG
| Study group | Role | What they receive |
|---|---|---|
| giving agonist ( eg. decapeptyl ) | Active comparator | Giving women agonist Receives: Drug: Agonist (decapeptyl ) |
| Giving HCG (eg. choriomon ) | Active comparator | Giving women HCG Receives: Drug: HCG ( eg. Choriomon ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of good quality embryos
how many good quality embryos
Measured: within 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start5 Feb 2021 (estimated)
- Primary completion25 Jun 2021 (estimated)
- Study completion1 Jul 2021 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749979
- Sponsor's protocol ID
- Oocyte
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin in IVF Cycles
- ClinicalTrials.gov ID
- NCT04749979
- Acronym / sponsor ID
- Oocyte
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 5 Feb 2021 (estimated)
- Primary completion
- 25 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 11 Feb 2021 (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.
Estradiol valerate in the form of cycloprogenova™ (white tablet only) was started on day 2 or 3 of cycle with oral dose 4 mg divided on 2 doses in addition to Aspocid 75 mg once daily with folic acid 500 mcg once daily.
Detailed description
U/S was done on day 9 or 10 of cycle to assess endometrial thickness, then every other day until endometrial thickness of 8 mm or more is reached and when endometrial thickness reaches 8 mm or more FET was planned. Progesterone in the form of prontogest™ 400 mg vaginal suppository twice dTwo to Four Day 5 Embryos was transferred
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| giving agonist ( eg. decapeptyl ) | Active comparator | Drug: Agonist (decapeptyl )Giving women agonist |
| Giving HCG (eg. choriomon ) | Active comparator | Drug: HCG ( eg. Choriomon )Giving women HCG |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PCOS patients according to Rotterdam criteria
- Female age between 20 and 40 years.
- Primary or secondary infertility.
- Body mass index (BMI) between 18 and 40 kg/m2.
Key exclusion criteria (3 listed)
- Ovarian endometriosis.
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 |
|---|---|---|
| Agonist (decapeptyl )giving agonist | Drug | giving agonist ( eg. decapeptyl ) |
| HCG ( eg. Choriomon )giving HCG | Drug | Giving HCG (eg. choriomon ) |
Primary outcome
the number of good quality embryos
Time frame: within 5 months
how many good quality embryos
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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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.
Mahmoud Alalfy, PhD principal investigator
Algezeera hospitaland National Research Centre ,Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agonist (decapeptyl ) and HCG ( eg. Choriomon ) in people with Infertility, run by Aljazeera Hospital 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 3 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 11 Feb 2021. 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?
Contact Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of good quality embryos (time frame: within 5 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 11 Feb 2021.