Invitro FertilizationNCT03402620
Poor Responders Infertile Patients -A Great Clinical Challenge
A study testing Gonadotropins in people with Invitro Fertilization, run by Cairo University at 1 site in Egypt.
Trial summary
infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Invitro Fertilization
- What is being tested?
- Gonadotropins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jan 2018to 4 Jun 2018
- 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 20 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Poor responders according to "Bologna consensus" with at least 2 of the following 3 points should be present:
- Age >40 years or other cause of poor function.
- AFC<2-5 in both ovaries or AMH < 0.5-1.1 ng/dl 2)
- History of poor response with conventional stimulation protocol
Who cannot join
- Uterine factor.
- Severe male factor.
- Endometriosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Starting Dose of Gonadotropin for Poor Responders in IVF Cycles
infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules
Read the detailed description
Participants will be randomized to start induction with 4 or 6 ampoules of gonadotropins from day 2 till the day of human chorionic gonadotropin (HCG), dose adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by TVUS scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day 6 for folliculometry and endometrial thickness and pattern. Cetrotide (MerckSerono, Germany) 0.25 subcutaneously will be added when the leading follicle (DF) reaches >12 mm and HCG 10 000 IU intramuscularly (Pregnyl, Merck Sharp, United Kingdom)will be given only if we have at least 3 mature follicles >14 mm and the leading one >17 mm; then, ovum pickup (OPU) was done after 36 hours of HCG and metaphase II ocytes were analyzed. The intracytoplasmic sperm injection (ICSI) procedure will be performed in all cases to avoid low fertilization rate by conventional IVF. Fertilization was assessed 16 to 18 hours after ICSI, and embryo quality will be evaluated 2 and 3 days after ICSI according to the number of blastomeres and the degree of fragmentation and multinucleation. Oocytes were collected and embryos will be cultured in ISM1 culture medium (Origiomedicult media, Denmark). Transfer of cleaving embryos will be done on day 3 after oocyte retrieval (using Labotect semirigid catheter; labotect GmbH, Germany), when the woman has at least 1 embryo (GI) otherwise canceled embryo transfer (ET). The ET was done by 1 person in each center. Both of the transferring consultants have more than 5 years experience in IVF unit. . All patients will receive luteal support in the form of daily progesterone cyclogest (Actavis, United Kingdom) 800 mg daily starting from day of ovum retrieval till day of hCG testing. Serum b hCG level was assessed on day 14 after ET and considered positive if >5 mIU/ml. The TVUS was performed 28 days after ET to confirm ongoing pregnancy by visualization of intrauterine sac.
- Conditions
- Invitro Fertilization
- Being tested
- Gonadotropins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GonadotropinsDrug
Human menopausal gonadotropin 75 IU ampoules start at cycle day 2
| Study group | Role | What they receive |
|---|---|---|
| four ampoules group | Active comparator | gonadotropin starting dose is 4 ampoules daily Receives: Drug: Gonadotropins |
| six ampoules group | Active comparator | gonadotropin starting dose is 6 ampoules daily Receives: Drug: Gonadotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of retrieved oocytes
The number of oocyte retrived at ovum pickup
Measured: 34 hours after HCG triggering
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start11 Jan 2018
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invitro FertilizationStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402620
- Sponsor's protocol ID
- 20
- Status last verified
- Jun 2018
- First submitted
- 11 Jan 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting Dose of Gonadotropin for Poor Responders in IVF Cycles
- ClinicalTrials.gov ID
- NCT03402620
- Acronym / sponsor ID
- 20
- Conditions
- Invitro Fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 18 Jan 2018 (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.
infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules
Detailed description
Participants will be randomized to start induction with 4 or 6 ampoules of gonadotropins from day 2 till the day of human chorionic gonadotropin (HCG), dose adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by TVUS scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day 6 for folliculometry and endometrial thickness and pattern. Cetrotide (MerckSerono, Germany) 0.25 subcutaneously will be added when the leading follicle (DF) reaches >12 mm and HCG 10 000 IU intramuscularly (Pregnyl, Merck Sharp, United Kingdom)will be given only if we have at least 3 mature follicles >14 mm and the leading one >17 mm; then, ovum pickup (OPU) was done after 36 hours of HCG and metaphase II ocytes were analyzed. The intracytoplasmic sperm injection (ICSI) procedure will be performed in all cases to avoid low fertilization rate by conventional IVF. Fertilization was assessed 16 to 18 hours after ICSI, and embryo quality will be evaluated 2 and 3 days after ICSI according to the number of blastomeres and the degree of fragmentation and multinucleation. Oocytes were collected and embryos will be cultured in ISM1 culture medium (Origiomedicult media, Denmark). Transfer of cleaving embryos will be done on day 3 after oocyte retrieval (using Labotect semirigid catheter; labotect GmbH, Germany), when the woman has at least 1 embryo (GI) otherwise canceled embryo transfer (ET). The ET was done by 1 person in each center. Both of the transferring consultants have more than 5 years experience in IVF unit. . All patients will receive luteal support in the form of daily progesterone cyclogest (Actavis, United Kingdom) 800 mg daily starting from day of ovum retrieval till day of hCG testing. Serum b hCG level was assessed on day 14 after ET and considered positive if >5 mIU/ml. The TVUS was performed 28 days after ET to confirm ongoing pregnancy by visualization of intrauterine sac.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| four ampoules group | Active comparator | Drug: Gonadotropinsgonadotropin starting dose is 4 ampoules daily |
| six ampoules group | Active comparator | Drug: Gonadotropinsgonadotropin starting dose is 6 ampoules daily |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Poor responders according to "Bologna consensus" with at least 2 of the following 3 points should be present:
Key exclusion criteria (3 listed)
- Uterine factor.
- Severe male factor.
- 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 |
|---|---|---|
| GonadotropinsHuman menopausal gonadotropin 75 IU ampoules start at cycle day 2 | Drug | four ampoules group, six ampoules group |
Primary outcome
number of retrieved oocytes
Time frame: 34 hours after HCG triggering
The number of oocyte retrived at ovum pickup
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 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Invitro Fertilization
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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 Maged, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropins in people with Invitro Fertilization, run by Cairo 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 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: finished, as of the sponsor's last update on 6 Jun 2018. 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?
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 retrieved oocytes (time frame: 34 hours after HCG triggering). 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 6 Jun 2018.