SubfertilityNCT02317978
Evaluation of the Role of Follicular Sensitivity Index in the Prediction of IVF/ICSI Outcome
An observational study of Subfertility, run by Cairo University at 1 site in Egypt.
Trial summary
Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) in Dar AlTeb sub-fertility center will be reviewed and the follicular sensitivity index (FSI) will be calculated and correlated with pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- ICSI
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2014to Oct 2016
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: The records of women who had IVF/ICSI without PCO will be reviewed to calculate the FSI.
Who may be able to join
- IVF/ICSI
Who cannot join
- Missing data
- Cancelled cycles.
- Polycystic ovarian syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) in Dar AlTeb sub-fertility center will be reviewed and the follicular sensitivity index (FSI) will be calculated and correlated with pregnancy.
Read the detailed description
The investigators study is a retrospective cohort study. Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) in Dar AlTeb sub-fertility center from January 2010 to December 2013 will be reviewed. All records with missing data will be excluded.
Triptorelin 0.1mg (Decapeptyl® Ferring, Germany) was used for pituitary down-regulation. It was given 7 days after the expected time of ovulation in women with regular cycles. Women with irregular cycles were given combined oral contraceptive pills and triptorelin was started on day 21 after starting the pills. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol were assessed and the antral follicular count (AFC) was assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.
Controlled ovarian hyperstimulation (COH) was started on the 2nd day of menstruation using human menopausal gonadotrophin (HMG) (Merional® IBSA, Switzerland). The initial dose ranged between 150-300 IU/day. The COH drug dose was adjusted according to the patient's response guided by number and size of the follicles in addition to serum E2 values. COH was continued until at least 3 follicles ≥17mm were obtained. This was followed by the administration of Human chorionic gonadotrophin (HCG) (Choriomon®, IBSA, Switzerland) 10000 IU. On the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal probe and the Preovulatory follicle count (PFC) was assessed, (PFC) was defined as number of follicles measuring≥16mm. FSI will be calculated as (FSI =PFC*10000/AFC*Total dose of FSH) Oocyte retrieval was guided by transvaginal ultrasound and was done 34-36 hours following HCG administration. Fertilization was done by ICSI. 16-18 hours later, fertilization was confirmed by the presence of 2 pronuclei.
The procedure was cancelled if less than 3 follicles ≥17 mm in size are present 12 days after starting FSH despite doses reaching 450 IU. The cycle was also cancelled if there is risk of ovarian hyperstimulation like massive ovarian enlargement or serum estradiol exceeds 3000pg/L The quality of embryos was assessed at day 3 according to the number and evenness of blastomeres in addition to the percentage of fragmentation. Embryos were classified into 3 groups: Excellent embryos containing 6-8 even blastomeres with <10% fragmentation, moderate embryos containing 6-8 even or uneven blastomeres with 10-20% fragmentation, and poor quality embryos containing less than 6 blastomeres or >20% fragmentation.
Embryo transfer was done on the 5th day after oocyte retrieval for couples who had IVF/ICSI. If possible, 2 embryos were transferred and cryopreservation of the remaining embryos was offered.
Luteal support was given in the form of progesterone vaginal tablets (Prontogest® IBSA, Switzerland) 400mg/day starting from the day of oocyte retrieval. A pregnancy test was done 2 weeks after embryo transfer and clinical pregnancy was defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer.
- Conditions
- Subfertility
- Being tested
- ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSIProcedure or surgery
records of women who had ICSI will be reviewed and analysed for determining FSI
| Study group | Role | What they receive |
|---|---|---|
| Subfertility without polycystic ovarian syndrome | The records of all women with infertility who had IVF/ICSI without polycystic ovarian syndrome (PCO) will be reviewed Receives: Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
FSI values will be classified into 3 groups: High, moderate and low. The proportion of women achieving a clinical pregnancy will be compared among the 3 groups. clinical pregnancy will be defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer.
Measured: 5 weeks after embryo transfer
Secondary outcomes (1)
Number of retrieved oocytes
FSI values will be classified into 3 groups: High, moderate and low. the number of retrieved oocytes will be compared among the groups
Measured: one hour after ovum pick-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdelGany Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317978
- Sponsor's protocol ID
- Sub8
- Status last verified
- Apr 2019
- First submitted
- 12 Dec 2014
- Last updated
- 22 Apr 2019
- Results posted
- No
Publications
Zhang N, Hao CF, Zhuang LL, Liu XY, Gu HF, Liu S, Chen ZJ. Prediction of IVF/ICSI outcome based on the follicular output rate. Reprod Biomed Online. 2013 Aug;27(2):147-53. doi: 10.1016/j.rbmo.2013.04.012. Epub 2013 May 4.
PubMed 23768619Broer SL, Mol BW, Hendriks D, Broekmans FJ. The role of antimullerian hormone in prediction of outcome after IVF: comparison with the antral follicle count. Fertil Steril. 2009 Mar;91(3):705-14. doi: 10.1016/j.fertnstert.2007.12.013. Epub 2008 Mar 5.
PubMed 18321493Melo MA, Garrido N, Alvarez C, Bellver J, Meseguer M, Pellicer A, Remohi J. Antral follicle count (AFC) can be used in the prediction of ovarian response but cannot predict the oocyte/embryo quality or the in vitro fertilization outcome in an egg donation program. Fertil Steril. 2009 Jan;91(1):148-56. doi: 10.1016/j.fertnstert.2007.11.042. Epub 2008 May 2.
PubMed 18455166
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Role of Follicular Sensitivity Index in the Prediction of IVF/ICSI Outcome
- ClinicalTrials.gov ID
- NCT02317978
- Acronym / sponsor ID
- Sub8
- Conditions
- Subfertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Dec 2014 (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.
Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) in Dar AlTeb sub-fertility center will be reviewed and the follicular sensitivity index (FSI) will be calculated and correlated with pregnancy.
Detailed description
The investigators study is a retrospective cohort study. Records of women who had in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) in Dar AlTeb sub-fertility center from January 2010 to December 2013 will be reviewed. All records with missing data will be excluded.
Triptorelin 0.1mg (Decapeptyl® Ferring, Germany) was used for pituitary down-regulation. It was given 7 days after the expected time of ovulation in women with regular cycles. Women with irregular cycles were given combined oral contraceptive pills and triptorelin was started on day 21 after starting the pills. On the second day of menstruation serum FSH, LH, Prolactin and Oestradiol were assessed and the antral follicular count (AFC) was assessed using a vaginal ultrasound scan. AFC will be defined as the number of follicles measuring 3-10mm.
Controlled ovarian hyperstimulation (COH) was started on the 2nd day of menstruation using human menopausal gonadotrophin (HMG) (Merional® IBSA, Switzerland). The initial dose ranged between 150-300 IU/day. The COH drug dose was adjusted according to the patient's response guided by number and size of the follicles in addition to serum E2 values. COH was continued until at least 3 follicles ≥17mm were obtained. This was followed by the administration of Human chorionic gonadotrophin (HCG) (Choriomon®, IBSA, Switzerland) 10000 IU. On the day of HCG administration, ovarian ultrasound scan will be performed using a transvaginal probe and the Preovulatory follicle count (PFC) was assessed, (PFC) was defined as number of follicles measuring≥16mm. FSI will be calculated as (FSI =PFC*10000/AFC*Total dose of FSH) Oocyte retrieval was guided by transvaginal ultrasound and was done 34-36 hours following HCG administration. Fertilization was done by ICSI. 16-18 hours later, fertilization was confirmed by the presence of 2 pronuclei.
The procedure was cancelled if less than 3 follicles ≥17 mm in size are present 12 days after starting FSH despite doses reaching 450 IU. The cycle was also cancelled if there is risk of ovarian hyperstimulation like massive ovarian enlargement or serum estradiol exceeds 3000pg/L The quality of embryos was assessed at day 3 according to the number and evenness of blastomeres in addition to the percentage of fragmentation. Embryos were classified into 3 groups: Excellent embryos containing 6-8 even blastomeres with <10% fragmentation, moderate embryos containing 6-8 even or uneven blastomeres with 10-20% fragmentation, and poor quality embryos containing less than 6 blastomeres or >20% fragmentation.
Embryo transfer was done on the 5th day after oocyte retrieval for couples who had IVF/ICSI. If possible, 2 embryos were transferred and cryopreservation of the remaining embryos was offered.
Luteal support was given in the form of progesterone vaginal tablets (Prontogest® IBSA, Switzerland) 400mg/day starting from the day of oocyte retrieval. A pregnancy test was done 2 weeks after embryo transfer and clinical pregnancy was defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subfertility without polycystic ovarian syndrome | – | Procedure: ICSIThe records of all women with infertility who had IVF/ICSI without polycystic ovarian syndrome (PCO) will be reviewed |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The records of women who had IVF/ICSI without PCO will be reviewed to calculate the FSI.
Key inclusion criteria (1 listed)
- IVF/ICSI
Key exclusion criteria (3 listed)
- Missing data
- Cancelled cycles.
- Polycystic ovarian syndrome.
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 |
|---|---|---|
| ICSIrecords of women who had ICSI will be reviewed and analysed for determining FSI | Procedure or surgery | Subfertility without polycystic ovarian syndrome |
Primary outcome
Clinical Pregnancy
Time frame: 5 weeks after embryo transfer
FSI values will be classified into 3 groups: High, moderate and low. The proportion of women achieving a clinical pregnancy will be compared among the 3 groups. clinical pregnancy will be defined as the presence of an intrauterine gestational sac 5 weeks after embryo transfer.
1 secondary outcome
Number of retrieved oocytes
Time frame: one hour after ovum pick-up
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 22 Apr 2019.
- Background: PubMed 23768619Zhang N, Hao CF, Zhuang LL, Liu XY, Gu HF, Liu S, Chen ZJ. Prediction of IVF/ICSI outcome based on the follicular output rate. Reprod Biomed Online. 2013 Aug;27(2):147-53. doi: 10.1016/j.rbmo.2013.04.012. Epub 2013 May 4.
- Background: PubMed 18321493Broer SL, Mol BW, Hendriks D, Broekmans FJ. The role of antimullerian hormone in prediction of outcome after IVF: comparison with the antral follicle count. Fertil Steril. 2009 Mar;91(3):705-14. doi: 10.1016/j.fertnstert.2007.12.013. Epub 2008 Mar 5.
- Background: PubMed 18455166Melo MA, Garrido N, Alvarez C, Bellver J, Meseguer M, Pellicer A, Remohi J. Antral follicle count (AFC) can be used in the prediction of ovarian response but cannot predict the oocyte/embryo quality or the in vitro fertilization outcome in an egg donation program. Fertil Steril. 2009 Jan;91(1):148-56. doi: 10.1016/j.fertnstert.2007.11.042. Epub 2008 May 2.
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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.
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?
An observational study of Subfertility, 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 1 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 22 Apr 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.
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?
Clinical Pregnancy (time frame: 5 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317978, which also lists 3 linked publications.
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 22 Apr 2019.