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Polycystic Ovary SyndromeFreFro-PCOSNCT01841528

Live Birth After Fresh Embryo Transfer Vs Frozen-thawed Embryo Transfer in Women With Polycystic Ovary Syndrome

A study testing fresh embryo transfer and frozen-thawed embryo transfer in people with Polycystic Ovary Syndrome and Infertility, run by Zi-jiang Chen at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of childbearing age. However, the optimal infertility treatment for PCOS patients is still a matter of controversy. Read more about this study

Who is it for?
Ages 20 to 34 years, women only
Conditions the study is for
Polycystic Ovary Syndrome, Infertility
What is being tested?
fresh embryo transfer and frozen-thawed embryo transfer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,180 participants
Where
14 sitesChina
Study dates
Jun 2013to Jun 2015
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 34 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women diagnosed as PCOS according to Chinese PCOS diagnosis criteria;
  • Women who have ≥1 years history of infertility;
  • Women aged ≥20 and <35 years old;
  • Women with body weight ≥40kg;
  • Women who have at least one of the following indications for IVF or ICSI:
  • Ovulation dysfunction and failed to become pregnant from ovulation induction treatment;
Show all 11Show fewer
  • Tubal factors: unilateral or bilateral tubal obstruction, adhesion, unilateral or bilateral Salpingectomy or tubal ligation;
  • Male factors: oligoasthenozoospermia, obstructive azoospermia;
  • Women who are undergoing their first cycle of IVF or ICSI;
  • Women who retrieved oocytes number > 3;
  • Women who are capable of giving informed consent.

Who cannot join

  • Women who underwent unilateral ovariectomy;
  • Women diagnosed as uterus abnormality: malformed uterus (uterus unicorns, septate uterus, duplex uterus, uterus bicomis), adenomyosis, submucous myoma, intrauterine adhesion;
  • Women or their partner with abnormal chromosome karyotype including chromosome polymorphism;
  • Women who have experienced recurrent spontaneous abortion (including biochemical pregnancy abortion) more than 2 times;
  • Women with medical condition that represent contraindication to assisted reproductive technology and/or pregnancy;
  • Women who has developed severe OHSS before oocyte pick-up day;
  • Women with retrieved oocytes number ≤3;
  • Women who are unable to comply with the study procedures.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • The sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Reproductive medical hospital affiliated to Shandong University

    Jinan, Shandong, 250001

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Guangxi Maternal and Child Health Hospital

    Nanning, Guangxi, 530003

  • Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

  • Reproductive Medicine Center in Shenyang City

    Shenyang, Liaoning, 110000

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Shanxi Provincial Maternity and Children's Hospital

    Xi’an, Shanxi, 710003

  • Yuhuangding Hospital in Yantai

    Yantai, Shandong, 264000

Other trials in China

About this study

Official title: Live Birth After Fresh Embryo Transfer vs Elective Embryo Cryopreservation/Frozen Embryo Transfer in Women With Polycystic Ovary Syndrome Undergoing IVF: A Multi-center Prospective Randomized Clinical Trial

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of childbearing age. However, the optimal infertility treatment for PCOS patients is still a matter of controversy. Despite producing more follicles and more oocytes than other women undergoing controlled ovarian hyperstimulation during an IVF cycle, women with PCOS have comparable or lower pregnancy rates. Additionally women with PCOS patients undergoing IVF have a higher risk of developing ovarian hyperstimulation syndrome (OHSS), which may be aggravated by pregnancy after an embryo transfer in a fresh cycle. Further women with PCOS are thought to have higher rates of later pregnancy complications including spontaneous abortion, pre-eclampsia, and preterm labor that may be related to impaired implantation in the superovulated endometrium. We propose a randomized clinical trial of elective embryo cryopreservation followed by a programmed cycle of endometrial preparation and frozen embryo transfer (FET) compared to fresh embryo transfer in women with PCOS undergoing in vitro fertilization (IVF).

Read the detailed description

This will be a multi-center, prospective, randomized (1:1 ratio)clinical trial of frozen-thawed embryo transfer vs. fresh embryo transfer after a uniform gonadotropin-releasing hormone (GnRH) antagonist protocol in infertile PCOS patients receiving IVF therapy. Qualified 1180 patients are randomized into either of two groups: group A will undergo fresh embryo transfer (590 cases), Group B will undergo elective cryopreservation of all embryos followed by transfer of thawed embryos to a programmed endometrium (590 cases). All of the participants will receive recombinant follicule stimulating hormone (rFSH)/GnRH antagonist protocol for ovarian stimulation and standardized luteal phase support.

The target population will be infertile PCOS patients aged between 20 and 35 years, diagnosed by the Chinese PCOS Criteria(i.e. menstrual disorders PLUS either one of the remaining two criteria, hyperandrogenism or polycystic ovaries on ultrasound, with exclusion of secondary causes of hyperandrogenism and ovulation dysfunction). And subjects will be those who are undergoing their first IVF or intracytoplasmatic sperm injection (ICSI) cycle without other known factors interfere reproductive or metabolic functions.

The randomization will take place at the oocyte pick-up day by an on-line randomization system.

The pregnancy test results, pregnancy complications, congenital anomalies neonatal complications will be followed up by checking medical records and telephone calls.

Being tested
fresh embryo transfer, frozen-thawed embryo transfer
Keywords
Polycystic Ovary Syndrome, Infertility, In-vitro fertilization, fresh embryo transfer, frozen-thawed embryo transfer
Medical subject headings
Polycystic Ovary Syndrome, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fresh embryo transferOther

    rFSH/GnRH antagonist will be administered for ovarian stimulation. Oocyte pick-up will be performed when at least two follicles ≥18mm. Two fresh embryos will be transferred at Day 3. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum HCG will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.

  • frozen-thawed embryo transferOther

    rFSH/GnRH antagonist will be administered for ovarian stimulation. Oocyte pick-up will be performed when at least two follicles ≥18mm. All embryos will be vitrified in fresh cycle, and at least 2 embryos should be frozen at Day 3. Two months later, two thawed Day 3 embryos will be transferred with HRT (hormone replacement therapy) prepared endometrium. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum HCG will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.

Study groups in NCT01841528
Study groupRoleWhat they receive
fresh embryo transfer groupExperimentalrFSH/GnRH antagonist will be administered for ovarian stimulation. Two fresh embryos will be transferred at Day 3. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum human chorionic gonadotropin (HCG) will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
Receives: Other: fresh embryo transfer
frozen-thawed embryo transfer groupExperimentalrFSH/GnRH antagonist will be administered for ovarian stimulation. All embryos will be vitrified in fresh cycle, and at least 2 embryos should be frozen at Day 3. Two months later, two thawed Day 3 embryos will be transferred with hormone replacement therapy (HRT) prepared endometrium. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum human chorionic gonadotropin (HCG) will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
Receives: Other: frozen-thawed embryo transfer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. live birth rate

    This will be based on the outcome of either the fresh embryo transfer after ovarian stimulation (Group A) or the outcome of the first frozen embryo transfer cycle (Group B) as will all other secondary outcomes.

    Measured: 10 months for group A, 12 months for group B

Secondary outcomes (8)

  1. Ovarian hyperstimulation syndrome (OHSS) incidence

    Measured: 2 months in maximum estimated

  2. clinical pregnancy rate

    This will be based on the visualization of a intrauterine gestational sac by ultrasound.

    Measured: 35 days after embryo transfer

  3. Pregnancy Loss rate

    Loss of pregnancy will be defined by any positive pregnancy test that does not result in a live birth and will be tracked.

    Measured: 28 weeks gestation in maximum

  4. ectopic pregnancy rate

    Measured: 7~8 weeks gestation

  5. singleton live birth rate

    Measured: 10 months for group A, 12 months for group B

  6. pregnancy complication rate

    Complications of pregnancy including gestational hypertension, diabetes, preterm labor, disorders of placentation will be collected in all patients with ongoing clinical pregnancies.

    Measured: 10 months for group A, 12 months for group B

  7. Congenital Anomalies rate

    We will collect all recognized fetal and infant anomalies that occur within the trial.

    Measured: 10 months for group A, 12 months for group B

  8. neonatal complication rate

    We will collect complications that occur in the neonate including admission to the neonatal intensive care unit (NICU), hospitalization, etc.

    Measured: within one month after labor

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

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
1,180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01841528
Sponsor's protocol ID
SDUIVF001
Acronym
FreFro-PCOS
Status last verified
Apr 2014
First submitted
18 Apr 2013
Last updated
16 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • [1] Boomsma CM, Eijkemans MJ, Hughes EG, et al. A meta-analysis of pregnancy outcomes in women with polycystic ovary syndrome. Hum Reprod Update 12:673-83,2006. [2] Hayashi M, Nakai A, Satoh S, et al. Adverse obstetric and perinatal outcomes of singleton pregnancies may be related to maternal factors associated with infertility rather than the type of assisted reproductive technology procedure used. Fertil Steril 98:922-928,2012. [3] Chen XK, Wen SW, Bottomley J, et al. In vitro fertilization is associated with an increased risk for preeclampsia. Hypertens Pregnancy 28:1-12,2009. [4] Thomopoulos C, Tsioufis C, Michalopoulou H, et al. Assisted reproductive technology and pregnancy-related hypertensive complications: a systematic review. J Hum Hypertens 27:148-57,2013. [5] Haavaldsen C, Tanbo T, Eskild A. Placental weight in singleton pregnancies with and without assisted reproductive technology: a population study of 536,567 pregnancies. Hum Reprod 27:576-82,2012. [6] Maheshwari A, Pandey S, Shetty A, et al. Obstetric and perinatal outcomes in singleton pregnancies resulting from the transfer of frozen thawed versus fresh embryos generated through in vitro fertilization treatment: a systematic review and meta-analysis. Fertil Steril 98:368-77 e1-9,2012. [7] Kalra SK, Ratcliffe SJ, Coutifaris C, et al. Ovarian stimulation and low birth weight in newborns conceived through in vitro fertilization. Obstet Gynecol 118:863-871,2011.

  • Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.

    PubMed 33539543

  • Wei D, Yu Y, Sun M, Shi Y, Sun Y, Deng X, Li J, Wang Z, Zhao S, Zhang H, Legro RS, Chen ZJ. The Effect of Supraphysiological Estradiol on Pregnancy Outcomes Differs Between Women With PCOS and Ovulatory Women. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2735-2742. doi: 10.1210/jc.2018-00613.

    PubMed 29718297

  • Zhang B, Wei D, Legro RS, Shi Y, Li J, Zhang L, Hong Y, Sun G, Zhang T, Li W, Chen ZJ. Obstetric complications after frozen versus fresh embryo transfer in women with polycystic ovary syndrome: results from a randomized trial. Fertil Steril. 2018 Feb;109(2):324-329. doi: 10.1016/j.fertnstert.2017.10.020. Epub 2018 Jan 17.

    PubMed 29338857

  • Wei D, Zhang B, Shi Y, Zhang L, Zhao S, Du Y, Xu L, Legro RS, Zhang H, Chen ZJ. Effect of Preconception Impaired Glucose Tolerance on Pregnancy Outcomes in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3822-3829. doi: 10.1210/jc.2017-01294.

    PubMed 28938429

  • Wei D, Shi Y, Li J, Wang Z, Zhang L, Sun Y, Zhou H, Xu Y, Wu C, Liu L, Wu Q, Zhuang L, Du Y, Li W, Zhang H, Legro RS, Chen ZJ. Effect of pretreatment with oral contraceptives and progestins on IVF outcomes in women with polycystic ovary syndrome. Hum Reprod. 2017 Feb;32(2):354-361. doi: 10.1093/humrep/dew325. Epub 2016 Dec 19.

    PubMed 27999118

  • Chen ZJ, Shi Y, Sun Y, Zhang B, Liang X, Cao Y, Yang J, Liu J, Wei D, Weng N, Tian L, Hao C, Yang D, Zhou F, Shi J, Xu Y, Li J, Yan J, Qin Y, Zhao H, Zhang H, Legro RS. Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome. N Engl J Med. 2016 Aug 11;375(6):523-33. doi: 10.1056/NEJMoa1513873.

    PubMed 27509101

  • Shi Y, Wei D, Liang X, Sun Y, Liu J, Cao Y, Zhang B, Legro RS, Zhang H, Chen ZJ. Live birth after fresh embryo transfer vs elective embryo cryopreservation/frozen embryo transfer in women with polycystic ovary syndrome undergoing IVF (FreFro-PCOS): study protocol for a multicenter, prospective, randomized controlled clinical trial. Trials. 2014 May 2;15:154. doi: 10.1186/1745-6215-15-154.

    PubMed 24885793

Questions about this trial

What is this clinical trial studying?

A study testing fresh embryo transfer and frozen-thawed embryo transfer in people with Polycystic Ovary Syndrome and Infertility, run by Zi-jiang Chen at 14 sites in China.

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 11 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: status not confirmed, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. 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?

Results are not available in the source record.

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?

live birth rate (time frame: 10 months for group A, 12 months for group B). 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 NCT01841528, which also lists 8 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 16 Apr 2014.

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