Infertility, FemaleNCT03105323
Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome
An observational study of Infertility, Female, run by Ain Shams Maternity Hospital.
Trial summary
This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital. Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 31 Mar 2018
- Phase
- Observational
- 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
Study population: This study will be conducted at the IVF Unit at Ain Shams University Maternity Hospital. Women will be recruited from the IVF Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
Who may be able to join
- Women with any type of subfertility undergoing IVF treatment.
- Age between (20-40) years old
- Body mass index between (20-40)
- Selected embryo are of grade 1 and 2 quality.
Who cannot join
- Age above 40 years old
- BMI above 40
- Bad quality embryo
- Uterine anomalies or malformation that affect embryo transfer.
Trial locations and contacts
No sites are listed yet.
About this study
This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital.
Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study The study will assess Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm Injection outcome.
Read the detailed description
Blood samples were collected on the day of final oocyte maturation, and serum Progesterone levels were measured using a chemiluminescent immunoassay for quantitative determination of the hormone .
The P/F ratio was calculated according to the equation (P(ng/mL)/number of follicles) and was defined by the measurements obtained on the day of final oocyte maturation.
All ultrasounds were performed at our In vitro fertilization center, and we included the number of follicles ≥14mm on the day of final oocyte maturation in the ratio calculation Oocytes were retrieved 36 hours after injection and were subsequently fertilized by In vitro fertilization or Intra cytoplasmic sperm injection. On day 2 - 5, all embryos were evaluated for cell number and morphology.
Each embryo transferred was evaluated for blastomere size and fragmentation. Embryos were graded as follows. Those with equal blastomere size and no fragmentation were considered Grade 1; those with blastomeres of equal size with slight fragmentation (<20 %) were Grade 2;those with blastomeres of unequal size but no fragmentation were Grade 3; those with blastomeres of equal or unequal size and moderate fragmentation (20 %-50 %) were Grade 4; and those with unrecognizable blastomeres and severe fragmentation (>50 %) were Grade 5.
The embryos were transferred on postretrieval day (2 - 5). Pregnancy was defined by Human chorionic gonadotropin titers within 11 days following Embryo transfer. Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.
- Conditions
- Infertility, Female
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| infertile women | All patients were pretreated with Gonadotropin releasing hormone agonist (decapeptyl®) 0.05 mg/day from 10 days prior to the start of menstruation. The patients'ovaries were stimulated with a recombinant follicle-stimulating hormone (FSH, subcutaneous) from day 2 of the menstrual cycle. human chorionic gonadotropin was administered when at least two follicles vary 18-22mm were observed on ultrasonography.Blood samples were collected on the day of final Human chorionic gonadotropin maturation, and serum P levels were measured.Pregnancy was defined by titers within 11 days following Embryo transfer,Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
rate of incidence of pregnancy after Intracytoplasmic Sperm Injection
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed nasr ali etman, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105323
- Sponsor's protocol ID
- ain shams university
- Status last verified
- Apr 2017
- First submitted
- 24 Mar 2017
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome
- ClinicalTrials.gov ID
- NCT03105323
- Acronym / sponsor ID
- ain shams university
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 7 Apr 2017 (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.
This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital.
Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study The study will assess Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm Injection outcome.
Detailed description
Blood samples were collected on the day of final oocyte maturation, and serum Progesterone levels were measured using a chemiluminescent immunoassay for quantitative determination of the hormone .
The P/F ratio was calculated according to the equation (P(ng/mL)/number of follicles) and was defined by the measurements obtained on the day of final oocyte maturation.
All ultrasounds were performed at our In vitro fertilization center, and we included the number of follicles ≥14mm on the day of final oocyte maturation in the ratio calculation Oocytes were retrieved 36 hours after injection and were subsequently fertilized by In vitro fertilization or Intra cytoplasmic sperm injection. On day 2 - 5, all embryos were evaluated for cell number and morphology.
Each embryo transferred was evaluated for blastomere size and fragmentation. Embryos were graded as follows. Those with equal blastomere size and no fragmentation were considered Grade 1; those with blastomeres of equal size with slight fragmentation (<20 %) were Grade 2;those with blastomeres of unequal size but no fragmentation were Grade 3; those with blastomeres of equal or unequal size and moderate fragmentation (20 %-50 %) were Grade 4; and those with unrecognizable blastomeres and severe fragmentation (>50 %) were Grade 5.
The embryos were transferred on postretrieval day (2 - 5). Pregnancy was defined by Human chorionic gonadotropin titers within 11 days following Embryo transfer. Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infertile women | – | –All patients were pretreated with Gonadotropin releasing hormone agonist (decapeptyl®) 0.05 mg/day from 10 days prior to the start of menstruation. The patients'ovaries were stimulated with a recombinant follicle-stimulating hormone (FSH, subcutaneous) from day 2 of the menstrual cycle. human chorionic gonadotropin was administered when at least two follicles vary 18-22mm were observed on ultrasonography.Blood samples were collected on the day of final Human chorionic gonadotropin maturation, and serum P levels were measured.Pregnancy was defined by titers within 11 days following Embryo transfer,Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will be conducted at the IVF Unit at Ain Shams University Maternity Hospital. Women will be recruited from the IVF Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study.
Key inclusion criteria (4 listed)
- Women with any type of subfertility undergoing IVF treatment.
- Age between (20-40) years old
- Body mass index between (20-40)
- Selected embryo are of grade 1 and 2 quality.
Key exclusion criteria (4 listed)
- Age above 40 years old
- BMI above 40
- Bad quality embryo
- Uterine anomalies or malformation that affect embryo transfer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical pregnancy rate
Time frame: a year
rate of incidence of pregnancy after Intracytoplasmic Sperm Injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Ain Shams Maternity Hospital.
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: status not confirmed, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Hashad (01006332360 ext. 02, a7mednasr@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: a year). 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 7 Apr 2017.