In Vitro FertilizationNCT05393011
Relationship Between Some Vitamins and Antioxidants With in Vitro Fertilization Outcomes
An observational study of In Vitro Fertilization and Infertility, run by Damascus University at 2 sites in Syria.
Trial summary
observation of females condition will getting pregnant by undergoing assisted reproductive technologies, the most important of which is the in vitro fertilization (IVF), where blood and follicular fluid samples are collected from them at the same stage of in vitro fertilization, and then monitor the IVF outcomes until… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- In Vitro Fertilization, Infertility
- What is being tested?
- human chorionic gonadotropin
- How many people
- 60 participants
- Where
- 2 sitesSyria
- Study dates
- 20 Aug 2017to 15 Aug 2021
- 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: Females attending Orient Fertility and Genetics Hospital for infertility treatment or pregnancy assistance
Who may be able to join
- Cases of Healthy women (in terms of reproductive function).
- Aged between 20-40 years and were close in terms of education, nutrition, and social status.
- Explicit male factor such as Oligospermia, Azoospermia, Asthenozoospermia, or TESA (Testicular Sperm Aspiration), ensuring that there is no fertility-interfering female factor.
- Undergoing long Gonadotropin-releasing hormone (GnRH) agonist down-regulation protocol.
Who cannot join
- Cases classified by the specialist clinician as a female factor such as PCOs (Polycystic Ovary Syndrome), Uterine Fibroids, Uterine Infections, Uterine Adhesions, and Endometriosis.
- Compound cases.
- Sex selection cases.
- Undergoing short GnRH agonist or antagonist protocol.
- Women aged under 20 or above 40.
- Women who took nutritional supplements, for at least two to three months before the egg retrieval procedure.
- Smokers.
- Cases with the following medical conditions: Tumors, Diabetes, Multiple sclerosis, Autoimmune Diseases, Liver or Kidney Disorders, Cushing's Syndrome, and women who take chronic medications
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Vitamin D and Some Antioxidants and Trace Elements Levels in Women: Relationship With I.V.F Outcomes
observation of females condition will getting pregnant by undergoing assisted reproductive technologies, the most important of which is the in vitro fertilization (IVF), where blood and follicular fluid samples are collected from them at the same stage of in vitro fertilization, and then monitor the IVF outcomes until pregnancy occurs or not, based on blood tests. The levels of interested markers in blood and follicular fluid samples of the study individuals are assayed in order to compare these levels with the egg criteria such as egg number and maturation rate and finally compare the results with occurrence or absence of pregnancy.
Read the detailed description
Vitamin D, vitamin E, zinc and glutathione peroxidase will be measured in blood and follicular fluid samples of study subjects for women undergoing in vitro fertilization after monitoring their health for two to three months before beginning the first stage of in vitro fertilization. Once start the ovulation induction protocol, which is the first stage of in vitro fertilization, we will monitor all the results from the number of eggs and follicles, their diameter, the thickness of the endometrium, the number of mature eggs, the egg maturation rate and fertilization rate to the occurrence of biochemical pregnancy or not later, based on the blood Human chorionic gonadotropin (hCG) levels two weeks after the embryos transfer to the uterus. The patient is monitored until clinical pregnancy is complete or not. On the other hand, we will later compare the levels of studied parameters with the aforementioned egg quality criteria and with the clinical pregnancy rate of the study group in order to understand the relationship between these studied parameters and the occurrence of pregnancy.
- Conditions
- In Vitro Fertilization, Infertility
- Being tested
- human chorionic gonadotropin
- Keywords
- Vitamin D, Vitamin E, Zinc, Glutathione peroxidase
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human chorionic gonadotropinDrug
Also called Chorex
10000 IU when at least three follicles become more than 16 mm
| Study group | Role | What they receive |
|---|---|---|
| Pregnant group | A female is considered pregnant when an explicit gestational sac inside the uterus is seen by ultrasound 4 weeks after embryo transfer. Receives: Drug: human chorionic gonadotropin | |
| Non-pregnant group | A female is considered not pregnant when no explicit gestational sac is seen inside the uterus by ultrasound 4 weeks after embryo transfer. Receives: Drug: human chorionic gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood and follicular fluid vitamin D concentrations
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Measured: Immediately after oocyte retrieval
Blood and follicular fluid vitamin E concentrations
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Measured: Immediately after oocyte retrieval
Blood and follicular fluid zinc concentrations
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Measured: Immediately after oocyte retrieval
Blood and follicular fluid glutathione peroxidase concentrations
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Measured: Immediately after oocyte retrieval
Secondary outcomes (7)
Number of oocytes retrieved
The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration after ovulation trigger
Measured: Immediately after oocyte retrieval
Number of Metaphase II Oocytes (MII)
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope
Measured: Within two hours after oocyte retrieval
Maturation Rate%
Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes
Measured: Within two hours after oocyte retrieval
Fertilization Rate%
Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes
Measured: 16-18 hours after microinjection
Embryo Quality
Embryos are assessed using Nikon SMZ1500 stereoscope
Measured: Day of transfer (2 or 3 days after microinjection)
Biochemical Pregnancy Rate%
Biochemical pregnancy is defined as a positive serum beta-hCG pregnancy test after 2 weeks of embryo transfer. The biochemical pregnancy rate is calculated by dividing the number of women who are biochemically pregnant by the number of women who have at least 1 embryo transferred
Measured: 2 weeks after embryo transfer
Clinical Pregnancy Rate% (Per Embryo Transfer)
weeks of embryo transfer. The clinical pregnancy rate is calculated as by dividing the number of women who are clinically pregnant divided by the number of women who have at least 1 embryo transferred
Measured: 4 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start20 Aug 2017
- Primary completion2 Aug 2020
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for In Vitro FertilizationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raghad MH Faisal, MD, Principal investigator, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393011
- Sponsor's protocol ID
- UDFP-Biochemistry-01-2022
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided: The study samples will be collected from female attending Orient Hospital (assisted reproduction and genetics) in order to carry out the in vitro fertilization process after obtaining the approval of the ethical committee of Damascus University, They will be informed with their husbands of the research objectives and sign the approve consent
Publications
Revelli A, Delle Piane L, Casano S, Molinari E, Massobrio M, Rinaudo P. Follicular fluid content and oocyte quality: from single biochemical markers to metabolomics. Reprod Biol Endocrinol. 2009 May 4;7:40. doi: 10.1186/1477-7827-7-40.
PubMed 19413899Lambalk CB, Banga FR, Huirne JA, Toftager M, Pinborg A, Homburg R, van der Veen F, van Wely M. GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type. Hum Reprod Update. 2017 Sep 1;23(5):560-579. doi: 10.1093/humupd/dmx017.
PubMed 28903472Aramesh S, Alifarja T, Jannesar R, Ghaffari P, Vanda R, Bazarganipour F. Does vitamin D supplementation improve ovarian reserve in women with diminished ovarian reserve and vitamin D deficiency: a before-and-after intervention study. BMC Endocr Disord. 2021 Jun 21;21(1):126. doi: 10.1186/s12902-021-00786-7.
PubMed 34154571Liu X, Zhang W, Xu Y, Chu Y, Wang X, Li Q, Ma Z, Liu Z, Wan Y. Effect of vitamin D status on normal fertilization rate following in vitro fertilization. Reprod Biol Endocrinol. 2019 Jul 18;17(1):59. doi: 10.1186/s12958-019-0500-0.
PubMed 31319865Bahadori MH, Sharami SH, Fakor F, Milani F, Pourmarzi D, Dalil-Heirati SF. Level of Vitamin E in Follicular Fluid and Serum and Oocyte Morphology and Embryo Quality in Patients Undergoing IVF Treatment. J Family Reprod Health. 2017 Jun;11(2):74-81.
PubMed 29282414Janati S, Behmanesh MA, Najafzadehvarzi H, Akhundzade Z, Poormoosavi SM. Follicular Fluid Zinc Level and Oocyte Maturity and Embryo Quality in Women with Polycystic Ovary Syndrome. Int J Fertil Steril. 2021 Jul;15(3):197-201. doi: 10.22074/IJFS.2021.135426.1006. Epub 2021 Jun 22.
PubMed 34155866Zal F, Ahmadi P, Davari M, Khademi F, Jahromi MA, Anvar Z, Jahromi BN. Glutathione-dependent enzymes in the follicular fluid of the first-retrieved oocyte and their impact on oocyte and embryos in polycystic ovary syndrome: A cross-sectional study. Int J Reprod Biomed. 2020 Jun 30;18(6):415-424. doi: 10.18502/ijrm.v13i6.7283. eCollection 2020 Jun.
PubMed 32754677
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Some Antioxidants and Trace Elements Levels in Women: Relationship With I.V.F Outcomes
- ClinicalTrials.gov ID
- NCT05393011
- Acronym / sponsor ID
- UDFP-Biochemistry-01-2022
- Conditions
- In Vitro Fertilization, Infertility
- Keywords
- Vitamin D, Vitamin E, Zinc, Glutathione peroxidase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 2 Aug 2020 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 26 May 2022 (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.
observation of females condition will getting pregnant by undergoing assisted reproductive technologies, the most important of which is the in vitro fertilization (IVF), where blood and follicular fluid samples are collected from them at the same stage of in vitro fertilization, and then monitor the IVF outcomes until pregnancy occurs or not, based on blood tests. The levels of interested markers in blood and follicular fluid samples of the study individuals are assayed in order to compare these levels with the egg criteria such as egg number and maturation rate and finally compare the results with occurrence or absence of pregnancy.
Detailed description
Vitamin D, vitamin E, zinc and glutathione peroxidase will be measured in blood and follicular fluid samples of study subjects for women undergoing in vitro fertilization after monitoring their health for two to three months before beginning the first stage of in vitro fertilization. Once start the ovulation induction protocol, which is the first stage of in vitro fertilization, we will monitor all the results from the number of eggs and follicles, their diameter, the thickness of the endometrium, the number of mature eggs, the egg maturation rate and fertilization rate to the occurrence of biochemical pregnancy or not later, based on the blood Human chorionic gonadotropin (hCG) levels two weeks after the embryos transfer to the uterus. The patient is monitored until clinical pregnancy is complete or not. On the other hand, we will later compare the levels of studied parameters with the aforementioned egg quality criteria and with the clinical pregnancy rate of the study group in order to understand the relationship between these studied parameters and the occurrence of pregnancy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant group | – | Drug: human chorionic gonadotropinA female is considered pregnant when an explicit gestational sac inside the uterus is seen by ultrasound 4 weeks after embryo transfer. |
| Non-pregnant group | – | Drug: human chorionic gonadotropinA female is considered not pregnant when no explicit gestational sac is seen inside the uterus by ultrasound 4 weeks after embryo transfer. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females attending Orient Fertility and Genetics Hospital for infertility treatment or pregnancy assistance
Key inclusion criteria (4 listed)
- Cases of Healthy women (in terms of reproductive function).
- Aged between 20-40 years and were close in terms of education, nutrition, and social status.
- Explicit male factor such as Oligospermia, Azoospermia, Asthenozoospermia, or TESA (Testicular Sperm Aspiration), ensuring that there is no fertility-interfering female factor.
- Undergoing long Gonadotropin-releasing hormone (GnRH) agonist down-regulation protocol.
Key exclusion criteria (8 listed)
- Cases classified by the specialist clinician as a female factor such as PCOs (Polycystic Ovary Syndrome), Uterine Fibroids, Uterine Infections, Uterine Adhesions, and Endometriosis.
- Compound cases.
- Sex selection cases.
- Undergoing short GnRH agonist or antagonist protocol.
- Women aged under 20 or above 40.
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 |
|---|---|---|
| human chorionic gonadotropinAlso: Chorex10000 IU when at least three follicles become more than 16 mm | Drug | Non-pregnant group, Pregnant group |
Primary outcome
Blood and follicular fluid vitamin D concentrations
Time frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Blood and follicular fluid vitamin E concentrations
Time frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Blood and follicular fluid zinc concentrations
Time frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
Blood and follicular fluid glutathione peroxidase concentrations
Time frame: Immediately after oocyte retrieval
Blood and Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until later assayed
7 secondary outcomes
Number of oocytes retrieved
Time frame: Immediately after oocyte retrieval
Number of Metaphase II Oocytes (MII)
Time frame: Within two hours after oocyte retrieval
Maturation Rate%
Time frame: Within two hours after oocyte retrieval
Fertilization Rate%
Time frame: 16-18 hours after microinjection
Embryo Quality
Time frame: Day of transfer (2 or 3 days after microinjection)
Biochemical Pregnancy Rate%
Time frame: 2 weeks after embryo transfer
Clinical Pregnancy Rate% (Per Embryo Transfer)
Time frame: 4 weeks after embryo transfer
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 26 May 2022.
- Background: PubMed 19413899Revelli A, Delle Piane L, Casano S, Molinari E, Massobrio M, Rinaudo P. Follicular fluid content and oocyte quality: from single biochemical markers to metabolomics. Reprod Biol Endocrinol. 2009 May 4;7:40. doi: 10.1186/1477-7827-7-40.
- Background: PubMed 28903472Lambalk CB, Banga FR, Huirne JA, Toftager M, Pinborg A, Homburg R, van der Veen F, van Wely M. GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type. Hum Reprod Update. 2017 Sep 1;23(5):560-579. doi: 10.1093/humupd/dmx017.
- Background: PubMed 34154571Aramesh S, Alifarja T, Jannesar R, Ghaffari P, Vanda R, Bazarganipour F. Does vitamin D supplementation improve ovarian reserve in women with diminished ovarian reserve and vitamin D deficiency: a before-and-after intervention study. BMC Endocr Disord. 2021 Jun 21;21(1):126. doi: 10.1186/s12902-021-00786-7.
- Background: PubMed 31319865Liu X, Zhang W, Xu Y, Chu Y, Wang X, Li Q, Ma Z, Liu Z, Wan Y. Effect of vitamin D status on normal fertilization rate following in vitro fertilization. Reprod Biol Endocrinol. 2019 Jul 18;17(1):59. doi: 10.1186/s12958-019-0500-0.
- Background: PubMed 29282414Bahadori MH, Sharami SH, Fakor F, Milani F, Pourmarzi D, Dalil-Heirati SF. Level of Vitamin E in Follicular Fluid and Serum and Oocyte Morphology and Embryo Quality in Patients Undergoing IVF Treatment. J Family Reprod Health. 2017 Jun;11(2):74-81.
- Background: PubMed 34155866Janati S, Behmanesh MA, Najafzadehvarzi H, Akhundzade Z, Poormoosavi SM. Follicular Fluid Zinc Level and Oocyte Maturity and Embryo Quality in Women with Polycystic Ovary Syndrome. Int J Fertil Steril. 2021 Jul;15(3):197-201. doi: 10.22074/IJFS.2021.135426.1006. Epub 2021 Jun 22.
- Background: PubMed 32754677Zal F, Ahmadi P, Davari M, Khademi F, Jahromi MA, Anvar Z, Jahromi BN. Glutathione-dependent enzymes in the follicular fluid of the first-retrieved oocyte and their impact on oocyte and embryos in polycystic ovary syndrome: A cross-sectional study. Int J Reprod Biomed. 2020 Jun 30;18(6):415-424. doi: 10.18502/ijrm.v13i6.7283. eCollection 2020 Jun.
- Individual participant dataSharing planned: Undecided. The study samples will be collected from female attending Orient Hospital (assisted reproduction and genetics) in order to carry out the in vitro fertilization process after obtaining the approval of the ethical committee of Damascus University, They will be informed with their husbands of the research objectives and sign the approve consent
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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.
Raghad MH Faisal, MD principal investigator
Damascus University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization and Infertility, run by Damascus University at 2 sites in Syria.
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 8 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 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Syria. 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?
Blood and follicular fluid vitamin D concentrations (time frame: Immediately after oocyte retrieval). The study lists 4 primary outcomes in all. 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 NCT05393011, which also lists 7 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 26 May 2022.