Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this prospective cohort study is to compare IVF outcome between tamoxifen and clomiphene citrate in mild stimulation.
The reported prevalence of poor ovarian responders amongst patients undergoing IVF-ET is 9%-24%, and morbidity must be higher nowadays. For these women, Mild stimulation has been an important ovulation induction protocol. Clomiphene citrate(CC) and tamoxifen(TMX) are commonly used in mild stimulation protocol. It's reported that CC has adverse effect on growth of endrometrium and results in thin endrometrium(≤7mm) which maybe affect pregnancy rate. However, TMX has estrogen-like effect on the endrometrium that may be helpful to increase endormetrial thickness. The reported results about comparing CC with TMX showed that they had similar ovulation rate. Prospective study is necessary to confirm whether TMX is superior to CC on the IVF outcome.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamoxifen | Experimental | All patients will have serum hormone examination and be monitored by transvaginal ultrasound for ovaries on the day 3 of the menses（D3）.Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from D3 for 5 days.All patients will check serum E2 and be monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness on the day 8 of the cycle. The investigators will add HMG and GnRH-ant according to follicular diameter,E2 and LH. Human chorionic gonadotropin(hCG) (5000-10000 IU IM) will be given when one follicle measured at least 18 mm is found. IVF or ICSI will be performed 34-36 h after hCG administration. All patients will receive luteal phase support with progesterone 60 mg im qd for 2 weeks. |
|
| clomiphene | Active Comparator | All patients will have serum hormone examination and be monitored by transvaginal ultrasound for ovaries on the day 3 of the menses（D3）.Patients in clomiphene group will take 100 mg of CC oral tablets daily from D3 for 5 days.All patients will have sexual hormone determination and be monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness on the day 8 of the cycle.The investigators will add HMG and GnRH-ant according to follicular diameter,E2 and LH. Human chorionic gonadotropin(hCG) (5000-10000 IU IM) will be given when one follicle measured at least 18 mm is found. IVF or ICSI will be performed 34-36 h after hCG injection. All patients will receive luteal phase support with progesterone 60 mg im qd for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from day 3 of the menses for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | four weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| cycle cancellations for thin endrometrial thickness | on the HCG day | |
| endrometrial pattern and thickness on the day of HCG administration | on the HCG day | |
| the number of follicular diameter≥10mm and sexual hormone test on the HCG day |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan LIN | Contact | 0018615913154456 | linhaiyan_818@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingxue ZHANG | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11334921 | Background | Boostanfar R, Jain JK, Mishell DR Jr, Paulson RJ. A prospective randomized trial comparing clomiphene citrate with tamoxifen citrate for ovulation induction. Fertil Steril. 2001 May;75(5):1024-6. doi: 10.1016/s0015-0282(01)01749-6. | |
| 21324155 | Background | Revelli A, Casano S, Salvagno F, Delle Piane L. Milder is better? Advantages and disadvantages of "mild" ovarian stimulation for human in vitro fertilization. Reprod Biol Endocrinol. 2011 Feb 16;9:25. doi: 10.1186/1477-7827-9-25. |
Not provided
Not provided
Yes
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clomiphene | Drug | Patients in clomiphene group will take 100 mg of CC oral tablets daily from day 3 of the menses for 5 days. |
|
|
| on the HCG day |
| 21831503 | Background | Badawy A, Gibreal A. RETRACTED: Clomiphene citrate versus tamoxifen for ovulation induction in women with PCOS: a prospective randomized trial. Eur J Obstet Gynecol Reprod Biol. 2011 Nov;159(1):151-154. doi: 10.1016/j.ejogrb.2011.07.015. Epub 2011 Aug 9. No abstract available. |
|
| 18616885 | Background | Wang CW, Horng SG, Chen CK, Wang HS, Huang HY, Lee CL, Soong YK. Ovulation induction with tamoxifen and alternate-day gonadotrophin in patients with thin endometrium. Reprod Biomed Online. 2008 Jul;17(1):20-6. doi: 10.1016/s1472-6483(10)60288-x. |
| 19775686 | Background | Reynolds K, Khoury J, Sosnowski J, Thie J, Hofmann G. Comparison of the effect of tamoxifen on endometrial thickness in women with thin endometrium (<7mm) undergoing ovulation induction with clomiphene citrate. Fertil Steril. 2010 Apr;93(6):2091-3. doi: 10.1016/j.fertnstert.2009.08.038. Epub 2009 Sep 22. |
| 23943795 | Background | Brinton LA, Westhoff CL, Scoccia B, Lamb EJ, Trabert B, Niwa S, Moghissi KS. Fertility drugs and endometrial cancer risk: results from an extended follow-up of a large infertility cohort. Hum Reprod. 2013 Oct;28(10):2813-21. doi: 10.1093/humrep/det323. Epub 2013 Aug 13. |
| 24592985 | Background | Ozcan Cenksoy P, Ficicioglu C, Kizilkale O, Suhha Bostanci M, Bakacak M, Yesiladali M, Kaspar C. The comparision of effect of microdose GnRH-a flare-up, GnRH antagonist/aromatase inhibitor letrozole and GnRH antagonist/clomiphene citrate protocols on IVF outcomes in poor responder patients. Gynecol Endocrinol. 2014 Jul;30(7):485-9. doi: 10.3109/09513590.2014.893571. Epub 2014 Mar 5. |
| 23008110 | Background | Pourmatroud E, Zargar M, Nikbakht R, Moramazi F. A new look at tamoxifen: co-administration with letrozole in intrauterine insemination cycles. Arch Gynecol Obstet. 2013 Feb;287(2):383-7. doi: 10.1007/s00404-012-2556-3. Epub 2012 Sep 25. |
| 23604525 | Background | Mazzarino M, Biava M, de la Torre X, Fiacco I, Botre F. Characterization of the biotransformation pathways of clomiphene, tamoxifen and toremifene as assessed by LC-MS/(MS) following in vitro and excretion studies. Anal Bioanal Chem. 2013 Jun;405(16):5467-87. doi: 10.1007/s00216-013-6961-7. Epub 2013 Apr 23. |
| 19821295 | Background | Brown J, Farquhar C, Beck J, Boothroyd C, Hughes E. Clomiphene and anti-oestrogens for ovulation induction in PCOS. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD002249. doi: 10.1002/14651858.CD002249.pub4. |
| 19944418 | Background | Zakherah MS, Nasr A, El Saman AM, Shaaban OM, Shahin AY. Clomiphene citrate plus tamoxifen versus laparoscopic ovarian drilling in women with clomiphene-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2010 Mar;108(3):240-3. doi: 10.1016/j.ijgo.2009.10.004. Epub 2009 Nov 26. |
| 15845599 | Background | Steiner AZ, Terplan M, Paulson RJ. Comparison of tamoxifen and clomiphene citrate for ovulation induction: a meta-analysis. Hum Reprod. 2005 Jun;20(6):1511-5. doi: 10.1093/humrep/deh840. Epub 2005 Apr 21. |
| 11075292 | Background | Wang HS, Wang TH, Soong YK. Cyclic changes in serum levels of insulin-like growth factor binding protein-1 in women treated with clomiphene citrate and tamoxifen. Gynecol Endocrinol. 2000 Aug;14(4):236-44. doi: 10.3109/09513590009167687. |
| 21745489 | Background | Mazzarino M, Bragano MC, de la Torre X, Molaioni F, Botre F. Relevance of the selective oestrogen receptor modulators tamoxifen, toremifene and clomiphene in doping field: endogenous steroids urinary profile after multiple oral doses. Steroids. 2011 Nov;76(12):1400-6. doi: 10.1016/j.steroids.2011.06.005. Epub 2011 Jun 30. |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |