InfertilityNCT02368964
IVF Treatment in Women With Immature Oocytes in Previous Cycle
A study testing GnRH agonist 0.2 mg + hCG 250 mcg and high dose hCG 500 mcg in people with Infertility, run by Sheba Medical Center at 1 site in Israel.
Trial summary
In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing hormone (LH) surge. 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?
- GnRH agonist 0.2 mg + hCG 250 mcg and high dose hCG 500 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2015to 1 Jun 2020
- 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
- Patients with low proportion of mature-MII oocytes oocytes (75%) per number oocytes retrieved at the prior IVF cycle
- Age between 18-42
Who cannot join
- Women with high ovarian response:anti-mullerian hormone ( AMH) >5, antral follicle count ( AFC) >15
- more than 20 oocytes retrieved at the prior cycle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment for Final Follicular Maturation Induction in Patients With Previous High Ratio of Immature Oocytes
In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually given between 12-24 hours before the hCG triggering dose.One protocol used at the investigators unit, after a cycle with low proportion of mature oocytes per number oocytes retrieved, is triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration.
Lately, new researches showed that dual triggering of final oocyte maturation with a combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders undergoing the GnRH-antagonist COH protocol
Read more
Another treatment option is high dose hCG. Only few case reports have described the use of high dose hCG after aspiration of non mature oocytes at a previous cycle. At the investigators IVF unit, patients with previous history of high percentage of immature oocytes retrieved, are triggered at the following cycle, either with double trigger or with high dose of hCG decided by the physician consulting the patient. It is still not known with which way of triggering more mature oocytes is retrieved.
The aim of this study is to perform a prospective randomized controlled study in patients with low proportion of mature-MII oocytes oocytes (<75%) per number oocytes retrieved, despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles triggered with high dose hCG to those triggered with hCG+GnRH agonist.
Read the detailed description
Patients will be prospectively randomized into two groups. The randomization will be organized through the computer. The hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration, and the Double trigger Group- will receive gonadotropin-releasing hormone (GnRH) agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration. All patients will be supplemented with the same progesterone preparation( Crinone gel 8% once a day) for luteal support. Women that suffer from vaginal spotting or vaginal bleeding during the luteal phase will receive supplementation of Geston 50MG intramuscular once every 2 days.
At the day of oocyte aspiration, blood will be drawn for serum LH, FSH, estrogen (E2) and progesterone. Moreover, clear follicular fluid will be collected and tested for LH, FSH, E2 and progesterone levels.
- Conditions
- Infertility
- Being tested
- GnRH agonist 0.2 mg + hCG 250 mcg, high dose hCG 500 mcg
- Keywords
- double triggering, Oocyte maturation, GNRH Agonist, hCG, IVF treatment, immature oocytes
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH agonist 0.2 mg + hCG 250 mcgDrug
Also called GnRH agonist - Decapeptyl , hCG - Ovitrelle
Treatment for triggering
high dose hCG 500 mcgDrug
Also called Ovitrelle
Treatment for triggering
| Study group | Role | What they receive |
|---|---|---|
| High dose hCG | Experimental | The hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration Receives: Drug: high dose hCG 500 mcg |
| Double trigger | Experimental | Double trigger Group- will receive GnRH agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration Receives: Drug: GnRH agonist 0.2 mg + hCG 250 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number MII oocytes per number of oocytes retrieved
Rate of mature oocytes from total oocytes retrieved
Measured: day of retrieving the oocytes
Secondary outcomes (3)
Total oocytes
Measured: day of retrieving the oocytes
Pregnancy rate
Measured: Two weeks from induction of ovulation
Number of top quality embryos
Measured: day of retrieving the oocytes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
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 InfertilityStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
- Investigators
- Aya Mohr Sasson, M.D, Principal investigator, Sheba Medical Center - IVF Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368964
- Sponsor's protocol ID
- SHEBA-14-1817-YH-CTIL
- Status last verified
- Jun 2022
- First submitted
- 10 Feb 2015
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamb JD, Shen S, McCulloch C, Jalalian L, Cedars MI, Rosen MP. Follicle-stimulating hormone administered at the time of human chorionic gonadotropin trigger improves oocyte developmental competence in in vitro fertilization cycles: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2011 Apr;95(5):1655-60. doi: 10.1016/j.fertnstert.2011.01.019.
PubMed 21315341Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.
PubMed 23993928Zilberberg E, Haas J, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG, for final oocyte maturation (double trigger), in patients with low proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.
PubMed 25385007
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Final Follicular Maturation Induction in Patients With Previous High Ratio of Immature Oocytes
- ClinicalTrials.gov ID
- NCT02368964
- Acronym / sponsor ID
- SHEBA-14-1817-YH-CTIL
- Conditions
- Infertility
- Keywords
- double triggering, Oocyte maturation, GNRH Agonist, hCG, IVF treatment, immature oocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 23 Feb 2015 (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.
In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually given between 12-24 hours before the hCG triggering dose.One protocol used at the investigators unit, after a cycle with low proportion of mature oocytes per number oocytes retrieved, is triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration.
Lately, new researches showed that dual triggering of final oocyte maturation with a combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders undergoing the GnRH-antagonist COH protocol
Another treatment option is high dose hCG. Only few case reports have described the use of high dose hCG after aspiration of non mature oocytes at a previous cycle. At the investigators IVF unit, patients with previous history of high percentage of immature oocytes retrieved, are triggered at the following cycle, either with double trigger or with high dose of hCG decided by the physician consulting the patient. It is still not known with which way of triggering more mature oocytes is retrieved.
The aim of this study is to perform a prospective randomized controlled study in patients with low proportion of mature-MII oocytes oocytes (<75%) per number oocytes retrieved, despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles triggered with high dose hCG to those triggered with hCG+GnRH agonist.
Detailed description
Patients will be prospectively randomized into two groups. The randomization will be organized through the computer. The hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration, and the Double trigger Group- will receive gonadotropin-releasing hormone (GnRH) agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration. All patients will be supplemented with the same progesterone preparation( Crinone gel 8% once a day) for luteal support. Women that suffer from vaginal spotting or vaginal bleeding during the luteal phase will receive supplementation of Geston 50MG intramuscular once every 2 days.
At the day of oocyte aspiration, blood will be drawn for serum LH, FSH, estrogen (E2) and progesterone. Moreover, clear follicular fluid will be collected and tested for LH, FSH, E2 and progesterone levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose hCG | Experimental | Drug: high dose hCG 500 mcgThe hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration |
| Double trigger | Experimental | Drug: GnRH agonist 0.2 mg + hCG 250 mcgDouble trigger Group- will receive GnRH agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with low proportion of mature-MII oocytes oocytes (75%) per number oocytes retrieved at the prior IVF cycle
- Age between 18-42
Key exclusion criteria (2 listed)
- Women with high ovarian response:anti-mullerian hormone ( AMH) >5, antral follicle count ( AFC) >15
- more than 20 oocytes retrieved at the prior cycle.
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 |
|---|---|---|
| GnRH agonist 0.2 mg + hCG 250 mcgAlso: GnRH agonist - Decapeptyl , hCG - OvitrelleTreatment for triggering | Drug | Double trigger |
| high dose hCG 500 mcgAlso: OvitrelleTreatment for triggering | Drug | High dose hCG |
Primary outcome
Number MII oocytes per number of oocytes retrieved
Time frame: day of retrieving the oocytes
Rate of mature oocytes from total oocytes retrieved
3 secondary outcomes
Total oocytes
Time frame: day of retrieving the oocytes
Pregnancy rate
Time frame: Two weeks from induction of ovulation
Number of top quality embryos
Time frame: day of retrieving the oocytes
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 24 Jun 2022.
- Background: PubMed 21315341Lamb JD, Shen S, McCulloch C, Jalalian L, Cedars MI, Rosen MP. Follicle-stimulating hormone administered at the time of human chorionic gonadotropin trigger improves oocyte developmental competence in in vitro fertilization cycles: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2011 Apr;95(5):1655-60. doi: 10.1016/j.fertnstert.2011.01.019.
- Background: PubMed 23993928Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.
- Background: PubMed 25385007Zilberberg E, Haas J, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG, for final oocyte maturation (double trigger), in patients with low proportion of mature oocytes. Gynecol Endocrinol. 2015 Feb;31(2):145-7. doi: 10.3109/09513590.2014.978850. Epub 2014 Nov 11.
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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.
Aya Mohr Sasson, M.D principal investigator
Sheba Medical Center - IVF Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRH agonist 0.2 mg + hCG 250 mcg and high dose hCG 500 mcg in people with Infertility, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 2 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 24 Jun 2022. 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 Israel. 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 MII oocytes per number of oocytes retrieved (time frame: day of retrieving the oocytes). 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 NCT02368964, 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 24 Jun 2022.